Cosmetics &Amp; Toiletries - May 2014 - Cosmeticsandtoiletries201405-13988677100005e00d10a77-Pp

7/25/2019 Cosmetics &Amp; Toiletries - May 2014 - Cosmeticsandtoiletries201405-13988677100005e00d10a77-Pp

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Genetic Pathways

Into Skin p 38

May 20 1 4

Magazine Tablet App Now Available!p 16, 17

Skin Mechanics with Age p 66

Re-activating Sunscreens p 84

Affecting Cholesterol, Enzymes in Skin p 22

Antimicrobial Stability During Use p 56


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2 |www.CosmeticsandToiletries.com Vol. 129, No. 4 | May 2014

Edit or 's not e | C&T

Years ago, Ken Klein reviewed an ar ticle submitted to Cosmetics

& Toiletries (C&T) on a cosmetic active. His feedback went

something like cosmetics should be cosmetic, not active, otherwise

they are drugs.He added that making such claims would draw the

scrutinizing eye of regulators. Many agree with this view. In fact,

the March 2013 cover of C&T featured an art icle on gene-silencing

for potential skin benets, and this stirred negative reactions from

readers. I wonder how the present cover fares?

To Klein's latter point, he was right. Several cosmetic

manufacturers have been issued warnings by the U.S. Food & Drug

Administration for making drug-like claims. To his

rst point,however, some argue cosmetics have always had eects on the body.

In the April 2013 GCI, Steve Herman observed, Cosmetic science

used to resemble cooking. Now, it is looking like peer-reviewed

genetic research squeezed into a jar.He added, Some would say

that in reality, beauty products have always [altered genes] to a

certain extent.C&T takes no stand on what cosmetics should or

shouldn't be. We're here to provide you insight to envision what

they could be and this edition looks farther out than ever before

to research and technologies with real potential.

For one, topically impacting the human epigenome has been

all the buzz, and in this issue, Epstein introduces this concept and

its pathways into skin. In relation, Dayan and Halperin present a

hypothesis for a specic fatty acid bile acid conjugate to aect skin

via cellular membrane transporters.Also looking to t he future, Wang details how a avobenzene

compound attached to a cholesterol group has the potential for

sunscreens that can re-activate [Wang will present Reactivating

Sunscreens via Azobenzene Compoundsat the Cosmetics &

Toiletries Summit (Summit.CosmeticsandToiletries.com) in June].

Freis et al. demonstrate the evolution of skin parameters with

aging, and identify a correlation between measured mechanical and

optical properties. And Bresciani et al. propose a method to assess

the antimicrobial ecacy of preservatives in cosmetics beyond

their containers i.e., during use.

Squeezing all this research into a jar may seem the work of

science ction, but it's of science fact. Even cosmetic cosmetics are

packing advanced particle science and optics into their compacts.

As knowledge and science continue to converge, who knows how

far next-generation products will reach.

NEXT-GEN COSMETICS

Rachel L. Grabenhofer

2 Editor's Note

4 Regular Contributors

6 Scientic Advisors

96 Advertiser Index

Market Intelligence

8 Turbulence in Emerging MarketsBut Cosmetics Will Prevail by R. Walker

10 Finished Product Launches

12 Read the Label: Ban Total RefreshCooling Body Cloths by S. Raffy

14 Technology Launches

Regulatory

18 Lead, Aluminum and Parabens: Myths inCosmetics by C. Flower, PhD, andE. Meredith, PhD

Research

22 Fatty Acid Bile Acid Conjugates Hypothesisfor Skin Anti-aging and Anti-acne Effectsby N. Dayan, PhD, and M. Halperin, MD

32 Understanding Fragrance Allergy,Is Fragrance-Free Always Necessary?

by H.I. Maibach, MD, et al.

38 Molecular Biology in Future Skin andHair Care by H. Epstein, PhD

46 Review and Modern Advances of Retinoidsfor Cosmetics by S. Isaacman, PhD, et al.

52 Patent Picks: Soft Hair Hold, Barrier Functionand More

Testing

56 Proposed Method to Evaluate theMicrobiological Stability of Cosmetics

During Use by N. Bresciani et al.

66 Correlating Aging with Skin's Mechanical andOptical Properties by O. Freis, PhD, et al.

Formulating

76 Approaches and Issues in PowderFormulations by P. Tsolis and G. Sahagun

84 Novel Azobenzene Compound to Extend andReactivate UV Protection by J.-Y. Wang, PhD,

and S. Geng

C&T May 20 1 4

CoverartbyJamesFergus


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4|www.CosmeticsandToiletries.com Vol. 129, No. 4 | May 2014

Regul ar Cont r ibut or s | C&T

EDITORIALEditorinChief JeffFalk 1-630-344-6071/ [email protected]

Editor RachelL.Grabenhofer 1-630-344-6072/[email protected]

AssociateEditor KatieAnderson 1-630-344-6077/[email protected]

ADVERTISINGSALESUS(NJ&PA),Canada, TomHarrisCentral&SouthAmerica 1-201-445-4702/[email protected]

AllUSstatesexceptNJ&PA KimJednachowski 1-630-344-6054/[email protected]

Europe&Asia JaneEvison 44(0)-1430-441685/[email protected]

Fragrance PaigeCri st

1-630-344-6060/[email protected]

AUDIENCEDEVELOPMENT&MARKETINGBrandSpecialist SteveOwen 1-630-344-6027/[email protected]

PUBLISHERGroupPublisher MarianRaney 1-630-344-6030/[email protected]

ExecutiveAssistant MariaRomero 1-630-344-6062/[email protected]

DESIGNDEPARTMENT

DesignManager AndrewFrederickProductionManager BryanCrowe

GraphicDesigner JamesFergus

CORPORATEPresident JanetLudwig

DirectorofMarketing LindaSchmitt

Controller LindaGetner

GroupShowDirector SandyChapin

OtherproductsbroughttoyoubyAllured:

Alluredbooks,Cosmetics&ToiletriesBenchReference(CBR),Cosmetics&Toiletriesmagazine:Portugueseedition,C&TSummit,GCI(GlobalCosmeticIndustry)magazine,Perfumer&Flavoristmagazine,Flavorcon,WorldPerfumeryCongress,Allured'sFFMBuyer'sGuide,SkinInc.magazine,Face&BodyMidwestSpaConference&Expo,andFace&BodyNorthernCaliforniaSpaConference&Expo

Cosmetics&Toiletries(ISSN0361-4387CTOIDG)ispublishedninetimesperyearasJan./Feb.,March,April,May,June,July/Aug.,Sept.,Oct.andNov./ Dec.byAlluredBusinessMedia.

Address:Cosmetics&Toiletries,336GundersenDrive,SuiteA,CarolStream,IL60188-2403|Tel:1-888-355-5962(9AM5PMCentral,MonFri)|Fax:1-630-653-2192|E-mail:[email protected]|www.CosmeticsandToiletries.com

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AlluredBusinessMediamakesallattemptstopublishaccurateinformation;however,thispublicationmaycontaintechnicalinaccuraciesortypographicalerrors.Thereaderassumesallrisksconcerning

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Copyright2014:AuthorizationtophotocopyarticlesandnewsisgrantedbyAlluredBusinessMedia,providedthatthefeeofUS$6percopyperitemispaiddirectlytotheCopyrightClearanceCenterTransactionalReportingService,21CongressSt.,SalemMa01970--PublicationNo.0361-4387CTOIDG/01/ $6.

Peter Tsolis has held various positions forthe past 14 years within e Este LauderCompanies R&D. He is an active memberof the Society of Cosmetic Chemists and

has presented on skin care formulation,delivery systems and new technology.

Susan Ray is president of Susan RayConsulting. She has more than 25 yearsof experience in personal care, including

a number of roles in R&D, businessdevelopment and technical sales. She is anactive member of the SCC and ACS.

MichaelIsaacman, PhD,is a chemistat Nanometics LLC and a postdoctoralresearcher at New York University. Hisresearch is focused on the synthesis andself-assembling dynamics of silicone-based amphiphilic block copolymers.

Steven Isaacman, PhD, holds advanceddegrees in organic a nd physical organicchemistry. He founded Nanometics LLCin 2006, where he leads research on novelmolecules, polymers and materia ls for

personal care and pharmaceuticals.

Howard I. Maibach, MD, is professor ofdermatology at the University of CaliforniaSchool of Medicine, San Francisco. Hislaboratory has been interested in and

published extensively on dermatopharma-cology and dermatotoxicology.

Chris Flower, PhD, director-general ofthe Cosmetic, Toiletry and PerfumeryAssociation (CTPA), joined CTPA aer25 years in cosmetic safety and R&D.He holds a doctorate from the CNAA intoxicology and physiology/pathology.

Emma Meredith, PhD, head of scienticand technical services at the CTPA, holdsa doctorate in pharmaceutical chemistryfrom the University of Strathclyde. She ispart icularly interested in sun protection,hair colorants and cosmetovigilance.

Nava Dayan, PhD, founded her researchconsultancy aer 24 years in skin care.She has written more than 150 articles

and four books, has been recognized forexcellence by the SCC and CRS, and wasawarded for innovation by In-Cosmetics.

p. 46 p. 46

p. 32 p. 76

p. 18 p. 18

p. 12 p. 22


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6 |www.CosmeticsandToiletries.com Vol. 129, No. 4 | May 2014

Scient ic Advisor y Boar d | C&T

Shuzo Ishidate,

PhDShiseido Research

Center

Russel Walters,PhD

Johnson & Johnson

GntherSchneider,

PhD

Beiersdorf AG

Leslie C. Smith,PhD

Coty-Lancaster

Eric Abrutyn

TPC2 Advisors

Ltd.

Sylvianne

Schnebert, MDLVMH Recherche

David C. Steinberg

Steinberg & Associates

Xiao Wu, PhDEli Lilly and Co.

Ron Sharpe

Amway Corp.

Shuliang Zhang,

PhD

Unilever

Prithwiraj Maitra,

PhD

Johnson & Johnson

Marc Pissavini,

PhD

Coty-Lancaster

Peter Tsolis

The Este LauderCompanies

Angela R. Eppler,PhD

Pzer Consumer

Healthcare

Trefor Evans,

PhD

TA Evans LLC

Sunscreen is the most potent anti-aging product on the market today.

Extreme multi-functionality is on the horizon; e.g., materials with anti-aging,

sunscreen, moisturizing and anti-free radical components in their structure, which

are slowly released to the skin, or that function continuously without being absorbed

in depth.

Mindy Goldstein,

PhD

Atlantic Coast

Media Group

S. Peter Foltis,PhD

L'Oral

Zoe Diana Draelos, MD

Dermatology

Consulting Services

Luigi Rigano, PhD

Industrial Consulting Research


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LexFeel

NaturalAn extremely light and dry emollientsuitable as a natural alternative tocyclomethicone and mineral oils.

Lexgard

NaturalA mild, natural, multi-functional emollient/humectant that assists in formulatingself-preserving cosmetics.

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Mar ket Int el l igence | C&T

ReproductioninEnglishoranyotherlanguageofallorpart

ofthisarticleisstrictlyprohibited.2014AlluredBusinessMedia.

The emerging economies are going through

a painful structural readjustment, and, asa result, the emerging middle class (a key

engine of growth for the beauty and personal

care industry over the last decade) is losing

some of its swagger.

In China, the combined pressures of a cool-

ing economy and more aggressive competition

from homespun and South Korean brands are

squeezing all the big multinationals. Tellingly,

newly released data from Euromonitor Inter-

national shows growth in China's beauty and

personal care market dropped below 9% last

year (at xed U.S. dollar values), its weakest

performance in two decades.Market conditions are tougher still in

Brazil and India. In both cases, middle-class

consumers have been trading down across a

raof beauty and personal care categories. e

negative tilt in market conditions in India has

taken the industry by surprise.

Pow er Shift DelayedAccording to the latest forecasts from

Euromonitor International, spending on beauty

and personal care in the emerging markets

will be higher than in the developed markets

by 2018. A year ago, this power shihad beenexpected to take place in 2016, but the choppier

economic waters have held things back. e

key point, however, is that emerging markets,

overall, still present a myriad of opportunities

for growth into the medium and long term,

despite the trickier operating conditions.

Turbulence in Emerging Markets

Rob Walker, Euromonitor International

n Growth in China's beauty and personal care marketdropped below 9% last year (at xed U.S. dollar values), itsweakest performance in two decades.

n In Brazil and India, middle-class consumers have beentrading down across beauty and personal care categories.

n Spending on beauty and personal care in emergingmarkets was expected to overtake spending in developedmarkets by 2016. Although this shift is expected to bedelayed until 2018, emerging markets, overall, still presenta myriad of oppor tunities for growth into the medium andlong term, despite the trickier operating conditions.

Quick Look

But Cosmetics Will Prevail

SavetoMyLibrary,aewWebtool.

ere were also some strong individual emerging market

performances last year. For example, sales of beauty and

personal care in Indonesia climbed 16%, fueled by a boomingmiddle class in secondary cities such as Balikpapan, Borneo.

Across the emerging markets, the big challenge is in adapting

a planning strategy to the changing climate, and in tailoring

products and marketing to the specic prole of consumers.

Editor's note: To read the full market report, see the May 2014

issue of GCI magazine or visit www.GCImagazine.com.


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Mar ket Inte l l igence | C&T

Finished Product Launches

Michael Todd True Organicsdebuted Wild Berry Exfoliating Peel. Fruit enzymes from wild blueberry,

strawberry, grape and raspberry, as well as alpha and beta hydroxy acids, work to exfoliate skin in order to

smooth ne lines and surface wrinkles, and improve skin texture and tone. Aloe works to oxygenate and

detoxify the skin for an added antioxidant and antibacterial benet.

Ingredients: Organic Aloe Leaf Juice, Isopentyldiol, Glycerin, Polysorbate 20, Lactic Acid, Rosehip

Seed Powder, L-Arginine, Decyl Glucoside, Salicylic Acid, Galactoarabinan, Mandelic Acid, Malic Acid,

Gluconolactone, Willow Bark Extract, Hawaiian Noni Fruit Extract, Bergamot Fruit Oil, Wild Blueberry

Fruit Extract, Grapefruit Extract, Grape Seed Extract, Raspberry Fruit Extract, Raspberry Seed Extract,

Cranberry Fruit Extract, Prune Fruit Extract, Cherry Fruit Extract, Wild Bilberry Fruit Leaf Extract,

Strawberry Fruit Extract, Rosa Canina Seed Powder, Blueberry Fiber, Ylang Ylang Flower Oil, OrangeOil, Pentylene Glycol, Butylene Glycol, Ethoxydiglycol, Sclerotium Gum, Sodium Benzoate, Methyl

Hydroxyethylcellulose, Dehydroacetic Acid, Ethylhexglycine.

Michael Todd True Organics | www.michaeltoddtrueorganics.com

Ingredients/claims are published as provided to C&T magazine by the manufacturers.

J.R. Watkins released an Anti-Aging Body Care System that includes a body wash, body cream, hand

cream and body serum. e Anti-Aging Body Serum utilizes the antioxidant power of cold-pressedgrape seed and blackberry seed oils, combined with plant-based moisturizers to leave skin more

hydrated. e serum also protects skin against oxidative damage and helps maintain skin's function.

Ingredients: Ant i-Aging Body Serum: Vitis Vinifera (Grape) Seed Oil, Macadamia Ternifolia SeedOil, Prunus Armeniaca (Apricot) Kernel Oil, Persea Gratissima (Avocado) Oil, Rubus Fruticosus

(Blackberry) Seed Oil, Fragrance (parfum), Tocopherol, Ascorbyl Palmitate, Retinyl Palmitate,

Carthamus Tinctorius (Saower) Seed Oil, Aloe Barbadensis Leaf Extract.

J.R. Watkins | www.jrwatkins.com

BLACKBERRYBODYSERUM

BERRYEXFOLIATOR

Pravana's new Nevo brand Super Shape, Lived-In, Twist and Detail hair care products include citric acidfor shine, sorbital for nourishment and body, and PVP for control and texture for hair. Specically, the

Lived-In Powder Potion styling product changes from a powder to a pomade for application, helping to

provide additional texture and styling capabilities.

Ingredients: Lived-in Powder Potion : Water (aqua), Aluminum Hydroxide, Glycerin, Sodium

Carboxymethyl Starch, PVP, Methyl Methacrylate Crosspolymer, Sorbitol, Phenoxyethanol,

Fragrance (parfum), Citric Acid.

AMAZON BOTANICALHAIRPOWDERPravana | www.pravana.com


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Expert in natural ingredients, NATUREX is launching NAT oleis , a range of botanical oils of exceptional

purity,selected from around the globe for their outstanding benets. These beauty oils are backed by

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Read the LabelBan Total RefreshCooling BodyCloths

Susan Ray, Susan Ray Consulting

e viewpoints expressed in this column are those of the author anddo not necessarily reect those of Cosmetics & Toiletries.

ANDIROBA NUTOIL

Yves Rocherhas released its Beautifying DryOil with andiroba nut oil, which oers a high

concentration of omega 9, to help nour ish skin.

It is also dry to the touch for a pleasant sensory

application experience.

Ingredients: Isopropyl Palmitate,Octyldodecanol, Coco-Caprylate/Caprate,

Ethylhexyl Palmitate, Ethylhexyl Stearate,

Hexyldecanol, Hexyldecyl Laurate, CarapaGuaianensis Seed Oil, Sesamum Indicum

(Sesame) Seed Oil, Fragrance (par fum),

Tocopheryl Acetate, BHT.

Yves Rocher | www.yvesrocherusa.com

Not Your Mother's has extended it s hair care

line with Plump For Joy ickening Hair Lier,a volumizing spray product including acrylates

to thicken hair and add body. Also, glycerin

helps to strengthen and add shine to hair.

Ingredients: Water, AMP-Acrylates/AllylMethacrylate Copolymer, Fragrance,

Glycerin, Polysorbate 20, Acrylates/

C10-30

Alkyl Acrylate Crosspolymer,

Aminomethyl Propanol, DMDM Hydantoin,

Methylparaben.

ACRYLATEHAIRLIFTERNot Your Mother's | www.nymbrands.com

Dial introduced Frozen Yogurt Cooling Body

Wash, which uses yogurt proteins as a natural

skin conditioner to help skin retain moisture

while providing nourishment. e product

also delivers a clean rinsing experience and

uses menthol to provide a cooling sensation to

the skin.

Ingredients: Water, Sodium LaurethSulfate, Cocamidopropyl Betaine, PEG-8,

Fragrance, Glycerin, Polyquaternium-7, Menthol, Ananas

Sativus (Pineapple) Fruit Juice, Carica Papaya (Papaya)Fruit Juice, Psidium Guajava Fruit Juice, Citrullus Lanatus(Watermelon) Fruit Juice, Hydrolyzed Yogurt Protein,

Propylene Glycol, Styrene/Acrylates Copolymer, PEG-7

Glyceryl Cocoate, PEG-200 Hydrogenated Glyceryl

Palmate, Cocamide MEA, Tetrasodium EDTA, Sodium

Benzoate, DMDM Hydantoin, Citric Acid, Sodium

Chloride.

Dial | www.dialsoap.comYOGURTBODYWASH


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Technology Launches

Croda has launched an ingredient designed

to smooth hair cuticles that have been

damaged or lied by bleaching or styling

processes. Crodabond CSA (INCI:

Hydrogenated Castor Oil/Sebacic Acid

Copolymer) is a conditioning treatment

that helps repair the damage caused by

at-home or salon chemical treatments.

e cuticle-sealing performance of the

copolymer is long-lasting, and its eects

can be imparted over multiple shampoo

washes. Treatment with the products results in hair that is smooth,

conditioned and healthy-looking. In addition, the treatment

prevented future damage. e ingredient is recommended at

0.5-5.0% in hair care, daily conditioners, intense conditioning

treatments and shampoos.

www.croda.com

Mibelle Biochemistry has sourced single-cell algae that grows on

glaciers at 0C to create its latest anti-aging active. Snow Algae

Powder (Pending INCI: Chlamydocapsa sp.-101 Extract (and)Maltodextrin (and) Lecithin (and) Water (aqua)) mimics the eects

of calorie restriction to improve the longevity of skin cells. e algae

adapt to their extreme habitat by changing pigment concentrations.

In addition, the production of secondary metabolites such as

biopolymers (gallerten), antifreeze glycoproteins, stress modiers and

osmotically active amino acids and sugars help these extremophile

algae to survive in their habitat. e company produces snow algae

powder sustainably in a tailor-made bioreactor.

At the cellular level, the active protects and activates two key factors

of the caloric restriction pathway the Klotho longevity gene and

the AMP-activated kinase (AMPK) energy sensor, which together

lead to improved cellular defenses, oxidative stress resistance, cell

detoxication and repair. Results in the skin are the initiation of

collagen production, and rejuvenation of the dermal-epidermal

junction. Consequently, the skin barrier is reinforced while the skin

appears fresher and detoxied, and age spots become less visible. e

active is recommended at 2-3% in rejuvenating and repair formulas,

age-defense products, youth-protecting and promoting skin care, and

formulas to increase skin's longevity.

www.mibellebiochemistry.com

Evonik has created a naturally derived solubilizerfor the formulation of lipophilic ingredients, such

as emollients and natural oils, into clear cosmetic

products. In addition to its solubilizing ability, TEGO

Solve 61 (INCI: Polyglyceryl-6 Caprylate (and)

Polyglyceryl-4 Caprate (and) Polyglyceryl-4 Cocoate

(and) Polyglyceryl-6 Ricinoleate) has good skin feel and

imparts moisturizing benets. e solubilizer is made

from 100% renewable raw materials and complies with

Ecocert standards.

Being easy to handle and cold processable, the ingredient allows for

the preparation of mixtures with oils and water. For example, fatty oils

such as avocado, olive, jojoba, sunower and argan, as well as caprylic/

capric triglyceride, can be incorporated into clear formulations. e

product was found to outperform PEG-40 hydrogenated castor oil in

solubilizing natural oils and in vivo, in a short-term moisturization test

using a corneometer, the solubilizer was found to act as a humectant

and provide moisturization from a body lotion. e solubilizer is

recommended at 0.510.0% in shampoos, body/hand/facial wash and

gel, makeup remover, emulsions and wet wipes.

personal-care.evonik.com

Induchem has launched

a natural exfoliant in two

grades that are non-irritating

to sensitive skin and

biodegradable. Biogomm'age

UE (INCI: Cellulose (and)

Hydroxypropylcellulose

(and) Tocopheryl Acetate

(and) CI77007) and Biogomm'age WD (INCI: Cellulose (and)

Hydroxypropylcellulose (and) Panthenyl Triacetate) are produced

with the company's Safe-scrub technology, enabling particles to self-

disintegrate upon use, thereby preventing skin irritation and avoiding

the skin redness typically seen aer exfoliation. is technology was

found to have the same exfoliation eciency as conventional apricot

kernel fragments of the same size distribution.

Biogomm'age UE, with pro-vitamin B5, helps to regenerate skin, and

Biogomm'age WD, with vitamin E, maintains skin barrier function.Each grade contains pigments in addition to the active that are available

in three sizes: 200 m, 400 m and 900m.

e exfoliants are stable in any formula type, but are recommended

for: leave-on whitening creams, to remove pigmented cells; dandru

shampoos, without leaving residue on an oily scalp; facial cleansers;

exfoliating lotions for sensitive skin; leave-on anti-aging serums, to

stimulate epidermal renewal; scrubbing hand sanitizers; and more. e

exfoliants are also compliant with Chinese regulations.

www.induchem.com

BIODEGRADABLEEXFOLIANT

LIPOPHILICSOLUBILIZER

HAIRSMOOTHING

ANTI-AGINGALGAE


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Reengineer ed

The App


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Red es igned Rel aunch ed

Pr emium Sponso r s :www.CosmeticsandToiletries.com/app

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app today to read and interact w ith C&T on the go.

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Regul at or y | C&T



T

here seem to be plenty of myths surrounding cosmetic products

and their ingredients. e rst of these is that a manufacturer would

deliberately use an ingredient that might lead to harm. Apart from

being illegal, it is not good for business to injure consumers, and successfulcompanies understand the needs of their consumers. is column will look

at some of the stories that are propagated online, and try to separate fact

from ction, as there is an element of both in all good myths.

Lead a nd Lipst ick e rst is that perennial favorite lead in lipstick. It has reappeared

several times in dierent guises, and has even been prompted by well-mean-

ing analysis of products by reputable agencies. Delving rst into the facts,

lead is harmful, but anything can be harmful if consumed excessively. ere

is no known biological use for lead in humans, so it is best avoided. But can

lead be avoided? Not completely, is the honest answer. Recognizing that lead

is harmful and not useful, lead has been removed from petrol (gasoline),

(most) paints, the solder used to seal cans for food, and household waterpipes. However, lead is present naturally in the environment, where it is

absorbed by plants from the soil, and is unavoidable in root vegetables.

Furthermore, because lead is ubiquitous, it is also found at trace levels in

some substances used to make products such as lipstick. It is not added

deliberately, but it cannot be completely avoided. e question is whether

the amount of lead in lipstick might be harmful to consumers, and the

answer is a clear no. In fact, Health Canada has said that people get more

lead from safe drinking water than the tiny traces present in lipstick.

is lead in lipstick myth is naturally related to two more myths that

women consume a given quantity (the exact amount varies with the

dierent stories) of lipstick in a lifetime, and that an individual can tell if

a lipstick contains lead by rubbing it on a gold ring. ink of how many

lipsticks a woman purchases per year, how much is leunused or discarded,and how much is leon tissues, drink ware and even the faces of friends

and family. One soon realizes that the estimated tubes of lipstick that a

woman consumes is, at best, an exaggerated guess.

As for the gold ring test, it is sheer nonsense. It takes the nest of

analytical chemists using the latest sophisticated equipment to measure t iny

traces of lead.

Chris Flower, PhD, and Emma Meredith, PhDCosmetic, Toiletry and Perfumery Association, London, UK

Lead, Aluminum and Parabens:

Myths in Cosmetics

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ABSTRACT

SavetoMyLibrary,anewWebtool.


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www.innospecinc.com

AMERICAS : ameri [email protected] ASIA-PACIFIC : [email protected]

EUROPE, MIDDLE EAST & AFRICA : [email protected]

CONNECTEDBY CHEM ISTRY

ALL THE INGREDIENTSFOR THE ULTIMATEFORMULATION

With a shared commit ment to creative

innovation, Innospec has integrated

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offer an unrivalled range of customizable

solutions.

Chemsil's high-quality speciality silicones

complement Innospec's extensive range of

personal care ingredients to deliver creative

formulation solutions. With a uniquely customer-

centric approach, we work in close collaboration

with formulators to support the development of

exciting products with real consumer appeal.

We can help you gain a market edge across

personal care categories, including:Hair care

Skin care

Sun care

Intimate care

For inspiration, ideas or further information,

please contact us.

Visit us at booth # 331, NYSCC Suppliers' Day

Edison, New Jersey, May 13 - 14 2014


24/102


Regul at or y | C&T

e cosmetic industry, however, should not be complacent. ere are,

unfortunately, some instances of illegal cosmetic products being discovered on

the market that are extremely high in lead, since in these cases, lead is one of the

main deliberate ingredients. e fact that such concoctions have been used in

some communities as traditional decorative products for generations does not

lessen the risk to those using them. ese are illegal cosmetics and should be

dealt with accordingly.

ParabensAnother myth surrounds the safety of parabens. ere have been reports that

these preservatives are linked to breast cancer through an ability to mimic thefemale hormone estrogen. Here, the facts are clear. Parabens are used as preser-

vatives to ensure that cosmetics remain wholesome and safe throughout their

use and do not have to be discarded quickly. Parabens are found in natu re; many

fruits contain parabens made by the plant itself to prevent the fruit from mold-

ing. Some parabens are able to mimic a portion of the properties of estrogen, but

not all of them. at mimicry is only seen under experimental conditions with

very high exposure or doses, and such conditions do not relate to everyday life.

Indeed, it is perfectly impossible for a human being to be exposed to sucient

parabens from cosmetic products to ever produce any disruption of the hormone

systemand even parabens found to mimic some properties of estrogen are

poor copies. Of course, many remember the study that claimed to have found

parabens in breast cancer tissues, but this study was poorly conducted and has

been strongly criticized by scientists. Parabens from an unidentied source hadcontaminated many of the samples, including the blank controls,which should

not have any parabens present.

Alum inum in Antipersp irantsMore recently, the cosmetic industry has seen concerns raised about the safety

of aluminum in antiperspirants. Aluminum is the most abundant metal on earth,

and is the third most abundant element. If it were particularly toxic, life itself

could not exist in its presence. In fact, aluminum has no known biological func-

tion in humans, and what humans absorb is readily removed via the kidneys.

It can cause harm when present in excess, which happens when kidneys

malfunction and when exposure is excessive with aluminum-based antacids or

during work in the aluminum industry. Any contribution from antiperspirant

use is small, particularly considering that aluminum compounds remain on thesurface of the skin to function by forming a gel to plug the sweat ducts. If the

aluminum was absorbed into the skin, the product would no longer work.

Conclusion ere are plenty more myths that have come and gone, but they all have

certain things in common: information is either exaggerated or not placed into

context, and incomplete information causes consumers to question where, in

fact, no problem exists. In all of these discussions, please remember that repu-

table cosmetics companies not only comply with strict legislation but want to

build a long-lasting relationship with their consumers, to have those consumers

stay loyal to the brand, and to make repeated purchases. is will not happen if

the company fails to provide satisfaction in terms of safety, ecacy and quality.


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Introducing Perlaura

Add more life to your skin care regimen with Perlaura

the new anti-aging active for visibly brighter, smoother skin.

Just one of many new ingredients you will nd in booth # 213

at the NYSCC Suppliers Day on May 13 & 14.

carecreations.basf.com


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Resear ch | C&T



F

atty acid bile acid conjugates (FABACs) are a family of small synthetic

molecules that init ially were developed as oral drugs to reduce fat

build-up and accumulation in the liver. e structure-activity rationale

is that the saturated fatty acid acts as a cholesterol solubilizing agent while

the bile acid acts as a vehicle to enable secretion into bile and penetrate into

the enterohepatic circulation. e amide bond further enhances stability

against intestinal degradation.1In the skin, however, cholesterol metabolism

diers dramatically. Skin renewal is maintained by controlling the balance

between proliferation, dierentiation and apoptosis of epidermal cells,2

and it has been shown that this program of epidermal dierentiation in

keratinocytes is altered when cholesterol-enriched domains in the plasma

membrane are disrupted.

Leveraging the innovation of FABACs in health care, the authors

developed a specic FABACabased on a cholesterol-solubilizing moiety,

i.e., saturated fatty acid, and a bile acid (cholic acid) as the vehicle to enable

secretion into bile and entry into the enterohepatic circulation for potential

skin benets.3, 4 is compound was chosen for its relatively low molecular

weight and lipophilicity, allowing it to penetrate skin, aect cholesterol

on the cell membrane level and facilitate other mechanisms. Previous

proteomic data has proven the activities of FABACs5-7in enhancing

ATP-binding cassette (ABCA1) cholesterol transporter and competitively

inhibiting stearoyl-CoA desaturase (SCD1) enzyme. erefore, it was

hypothesized that the developed FABAC would aect skin in similar ways.

In this paper, the mechanisms of ABCA1 cholesterol transporter and

SCD1 enzyme in the skin are detailed rst, highlighting the structure-activ-

ity relationships (SARs) involved. Following this, in vitro screenings of the

FABACaactive are described; screenings determined the level that activity

was occurring. Interestingly, compiled results suggest activities comparable

to retinoic acid the only drug currently prescribed for skin aging and

known for anti-acne eects (see Page 46 for more on this ingredient).

However, retinoic acid acts through nuclear receptors, whereas the new

FABAC is believed to act on cellular membrane transporters and competi-

tively inhibit enzymes by depleting cholesterol from the membrane, thereby

changing membrane uidity and the exposure of membrane-anchored

Nava Dayan, PhD

Dr. Nava Dayan LLC, NJ, USA

Maya Halperin, MD

Galderm Therapeutics, Tel Aviv, Israel

Fatty Acid Bile Acid Conjugates

Hypothesis for Skin Anti-aging

and Anti-acne Effects

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aSteamchol, Galderm erapeutics



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Resear ch | C&T

receptors. is milder yet eective mode of action is

an attr active option due to its larger margin of safety.

Cho leste rol in Skin e skin is a site of active lipid synthesis. In the

stratum corneum, aliphatic lipids are synthesized

de novo in the epidermis via phospholipids, and

cholesterol is synthesized from acetate within hours

aer induction (see Figure 1); cholesterol esters are

produced three to seven days later. e skin's lipid

prole aects its ability to serve key functions, suchas acting as a barrier against insult and preventing

water loss from the body.

Cholesterol is the second most abundant lipid

in the stratum corneum aer ceramideswhich

account for up to 50% w/w of total intercellular lipids.

Cholesterol is known to promote the intermixing of

dierent lipid species and to regulate their thermody-

namic phase behavior. Cholesterol esters, i.e., the next

step in the synthesis chain, contain unsaturated and

saturated diacyl chains that contribute to the stratum

corneum's stability and uidity, and promote its liquid

condensed state. In these capacities, both cholesterol

and its esters serve a fundamental role in skin's lateral

lipid organization, and their ratio controls skin bar-

rier properties.8

Since skin stem cells undergo terminal dierentia-

tion, and skin acts in some aspects as a separate

entity,as several compartments in the skin are not in

equilibrium with the body's circulation, and, there-

fore, it fullls its own needs from the blood. Further,

the metabolic pathways of skin lipids are dierent

from the pathways in internal organs and blood;

consequently, there is no correlation between the

cholesterol levels in blood and skin.

e skin barr ier renewal process involves the

generation and secretion of lamellar bodies or

granules from keratinocytes into the extracellular

matr ix (ECM), which requires utilizing a battery

of enzymes.9 ese lamellar bodies contain lipid

precursors such as glucosylceramides, cholesterol,

glycerophospholipids and sphingomyelin, as wellas catabolic enzymes such as proteases, lipases, acid

phosphatase and glucosidases. Such lipid precursors

are metabolized in the ECM and fused end-to-

end, forming progressively elongated membrane

sheets the intercellular lipid lamellar structure of

the stratum corneum.

Under basal conditions, lamellar body secretion is

relatively slow and corresponds to the kinetics dem-

onstrated by Hedberg and Wertz.10However, when

acute insult to the barrier is applied, this process is

accelerated to promote a sequence of recovery that

is achieved aer 72 hr in young skin (i.e., 20s/30s).

is sequence includes increases in cholesterol, freefatty acids and ceramide synthesis, all of which are

restricted to the underlying epidermis at the injured

site and dependent upon a prior up-regulation of

mRNA encoding to synthesize anabolic enzymes.

Since the synthesis of each of these key lipids is

essential for maintaining normal barrier properties,

inhibiting their synthesis may lead to abnormalities

and an impaired barrier that is more permeable.

Cholester ol Regulat ion,ABC A1 and SCD1

Keratinocytes require abundant amounts of

cholesterol for maintaining a strong barrier and

controlling cutaneous permeability; hence, the

regulation of cholesterol homeostasis in the skin

is of great importance. ABCA1 plays a pivotal role

for cholesterol eux. It regulates cholesterol levels

by promoting the transport of cholesterol and

Skin b arrier renew alinvolves the generation

and sec retion of lam ellarbodies into the ECM .

Figure 1.Synthesis path o f cho lesterol in skin

HMGCoA

SynthaseHMGCoA

Reductase FPPSSqualene

Synthase

AcetateHMGCoA Melvalonate Farnesol Squalene Cholesterol

EnzymeSubstrate


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Vol. 129, No. 4 | May 2014 Cosmetics & Toiletries|25

phospholipids across cell membranes. Jiang et al.11

demonstrated the expression of ABCA1 in human

keratinocytes and murine epidermis, conrming its

localization both in the outer epidermis, i.e., stra-

tum corneum and stratum granulosum, and lower

compartments including the stratum spinosum and

stratum basale. e activation of ABCA1 was shown

to lead to the activation of the retinoid X receptor in

keratinocytes and in macrophages.12

Jiang et al. also demonstrated that acute disrup-

tion of the barrier by tape-stripping or the applicationof acetone increases the synthesis of cholesterol and

suppresses the expression of ABCA1 transpor ter;

that way, cholesterol remains local and is available for

rapid barrier repair. Conversely, facilitating ABCA1

activity results in transport of cholesterol into the cell,

reducing the presence of cholesterol in the keratino-

cyte membrane and stratum corneum. is suggests

the ABCA1 transporter may be linked to keratinocyte

dierentiation.

In relation, studies13point toward a cascade

connection between stearoyl-CoA desaturase (SCD1)

enzyme inhibition and ABCA1 activation in skin.

Mice decient in SCD1 demonstrated sebaceousgland atrophy, depletion of sebaceous lipids, dry

skin and alopecia. Interestingly, researchers suggest

that the deletion of SCD1 and resulting reduction

in sebaceous lipids may be of value in the treatment

of Acne vulgaris, which is associated with increased

sebaceous gland activity.

Cholester ol and Lipid RaftsA closer investigation of cholesterol points to its

indirect role in controlling cell cycles. It accomplishes

this via receptors and transporters at the cell mem-

brane, aecting the organization of protein-binding

functions, in turn changing the protein conformation

and interacting with nearby clusters. e plasma

membrane of cells is made up of a combination of

glycosphingolipids and protein receptors organized

in glycolipoprotein micro-domains referred to as

lipid ras (see Figure 2). ese specialized entities

compartmentalize cellular processes by organizing

the assembly of signaling molecules, inuencing

membrane uidity and tracking membrane pro-

teins. Lipid ras are more ordered and tightly packed

than the surrounding and relatively uid bilayer but

oat freely in the membrane bilayer. ey have beendescribed as small (10-200 nm), heterogeneous,

highly dynamic, sterol and lipid enriched domains.

Further, small ras can sometimes be stabilized to

form larger platforms through protein-protein and

protein-lipid interactions.14

One key dierence between lipid ras and the

plasma membrane from which they are derived is the

lipid composition. Research has shown15that lipid

ras generally contain three to ve times the amount

of cholesterol found in the surrounding bilayer.

Cholesterol interacts preferentially, although not

exclusively, with sphingolipids due to their structure

and the saturation of the hydrocarbon chains. Soalthough not all of the phospholipids within the ra

are fully saturated, the hydrophobic chains of the

lipids contained in the ras are more saturated and

tightly packed than the surrounding bilayer. Choles-

terol can be viewed as the dynamic glue that holds

the ratogether.

Due to the rigid nature of the sterol group,

cholesterol partitions into the lipid ras where the

acyl chains of lipids tend to be in a lessuid state.

One important property of membrane lipids is their

amphiphilic characterhaving a polar, hydrophilic

head group and a non-polar, hydrophobic region.

Cholesterol has the ability to pack in between the

Figure 2.Illustration o f lipid raf t; reg ion 1) is standard lipid b ilayer w hile region 2) is a lipid raft

* 1) Non-raft membrane, 2) Lipid raft, 3) Lipid raft associated transmembrane protein, 4) Non-raft membrane protein, 5) Glycosylation

modications (on glycoproteins and glycolipids), 6) GPI-anchored protein, 7) Cholesterol, 8) Glycolipid


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Resear ch | C&T

lipids in ras, serving as a molecular spacer and lling

any voids between associated sphingolipids. e depletion

of cholesterol from lipid ras has been shown to change

their organization and aect keratinocyte dierentiation. It

was demonstrated, for example, that when lipid ras were

treated with low concentrations of methyl-beta cyclodex-

trin, which entrapped cholesterol and removed it from

the ra, a signicant decrease in keratin 1 and 10 early

dierentiation markers was observed.16

M ater ia ls and M ethodsBased on the biology and SARs, as stated previously, it

was hypothesized that the specied FABAC would enhance

ABCA1 cholesterol transporter and competitively inhibit

SCD1 enzyme. us, its eects were assessed in vitro via a

gene expression assay, described here.

Full thickness model: Gene expression was measured in

a full-thickness skin culture modelb. e FABACaingredi-

ent was applied to the surface of each test culture at a

concentration of 0.5% and collected 24 hr post-application.

Cultures treated with 10 mL 100% DMSO served as the

vehicle control group. Tissues were collected in an RNA

stabilization solutionc, and gene expression was analyzed

using validated assaysd. A set of 94 genes known for func-tions in the skin were evaluated, including ABCA1 and

SCD1 genes. Statistics were carried out using sowaree.

Results and Disc ussionOf the 94 selected genes used in the panel, only

twokeratin 1 and 10 (KRT 1 and 10)demonstrated

statistically signicant deviations in expression (see

Table1). ABCA1 and SCD1 mRNas were not altered

by the FABAC at the gene expression level as expected.

However, considering the SARs and previous proteomic5-7

data, these ndings, in fact, support the theory of eects

being conned to the protein level. Further, the FABAC

was speculated to be depleting cholesterol levels in lipidras. As noted, the depletion of cholesterol from lipid ras

was shown to change their organization and signicantly

decrease keratins 1 and 10; here, KRT 1 and 10 were

reduced. To elucidate the receptors being aected further,

additional studies are planned.

Table 1.Statist ically Sign icant Fold-changeData for 0.5% FABACavs. DMSO Contro l

Gene ID Gene name Fold-change

KRT10 keratin 10 -2.6

KRT1 keratin 1 -2.49

bEpiderm FT, MattekcRNAlater, AMBION, Inc.dTaqMan, Roche Molecular Systems, Inc.eStatMiner soware v4.2, Integromics Inc.


31/102


Ke ra tins 1 and 10To further understand the eects of the speci-

ed FABAC, consider the role of keratinocytes.17

Keratins are heteropolymeric structural proteins

that form the intermediatelament. ese laments,

along with actin microlaments and microtubules,

compose the cytoskeleton of epithelial cells. e

intermediatelaments are assembled from keratin

monomers, and the cornied envelope is assembled

from a protein called involucrin, as well as others.Involucrin is synthesized in the stratum spinosum,

where it is cross-linked by transglutaminase enzyme,

which further stabilizes it. us, involucrin provides

structural support to the cell and allows for resistance

to microorganisms. Involucrin also binds to loricrin,

another protein, and contributes to the formation of

the cornied envelope.

Keratins 1 and 10 are heterodimers and major

constituents of the intermediate lament cytoskel-

eton in the superbasal epidermis. Both keratins

are expressed in the spinous and granular layers

of the epidermis. Type II cytokeratins consist of

basic or neutral proteins that are arranged in pairsof heterotypic keratin chains co-expressed during

the dierentiation of simple and stratied epithelial

tissues. e down-regulation of keratins 1 and 10 has

been associated with the up-regulation of involu-

crin, and both have been shown to be triggered by

exposure to retinoic acid.18

e up-regulation of involucrin production, as

a result of the down-regulation of keratins 1 and

10, can therefore be explained as a compensation

mechanism that allows the epidermis to maintain

its integrity in spite of the attenuated dierentiation.

Table 2 cross-sections the normal human skin, out-

lining its layers, corresponding cell types, expressed

keratins and other markers. It should be noted that

the expression of keratins 1 and 10 is linked to the

expression of involucrin and conned to the epider-

mal spinous layer in which critical biochemical

paths that determine the integrity of the barrier and

its appearance are found.

Following the expression of keratins 1 and 10,

pro-laggrin, an important marker, is expressed and

leads to the generation of laggrin, a cationic protein

specic to the stratum corneum. Taken together,

in theory, the FABAC's attenuation of keratinocyte

dierentiation and depletion of cholesterol from lipid

ras could lead to a compensation mechanism that

results in accelerated proliferation and barr ier rejuve-

nation, potentially renewing the skin and aecting its

appearance. Additional studies are under way.

Retinoic Ac id, andKe ra tins 1 and 10

Retinoic acid is the active form of vitamin A. e

four most common indications for retinoids are:

acne, wrinkles, photo-damaged skin and inheritable

keratiopathieshowever, the potential for terato-

genic eects from the use of retinoids in women

of children-bearing age is a key consideration.19In

addition, it is well-established that a common adverse

eect from retinoid treatments is skin irr itation,

although the exact mechanism is not fully elucidated.

e general hypothesis is that retinoids normalize

keratinocyte dierentiation; other possible mecha-

nisms include the down-regulation of desmosomal

proteins, anti-proliferative eects, regulating lipid

synthesis, growth factors and cytokines.

Unlike the theoretical mechanism of the new

FABACa, retinoids exert their eects entirely through

nuclear receptors. ere are at least six retinoic acid

receptors belonging to two families: retinoic acid

receptors (RARs) and retinoid X receptors (RXRs).

Nuclear receptors expressed in keratinocytes include

these two families of receptors, vitamin D3 receptor

and thyroid hormone receptor. All of these can aect

keratinocyte dierentiation. For example, the RAR

gamma receptor for retinoic acid plays an important

role in the morphogenesis and dierentiation of

squamous epithelia.

Retinoic acid has been shown to inhibit the

activity of keratinocyte transglutaminase and the

formation of the cornied envelope. Similar to the

Table 2.Norm al Human Skin Layers, Corresponding Ce ll Types, Expressed Keratinsand Other Markers

Skin sub tissue Cell type Expressed keratins Other markers

Stratum corneum Corneocyte Cornied envelopeStratum granulosum Granular keratinocyte Keratin 2 Loricrin, laggrin

Stratum spinosum Spinous keratinocyte Keratins 1 and 10 Involucrin

Stratum basale Basal keratinocyte Keratins 5 and 14 Integrins

Stratum dermis Fibroblast None Collagen and elastin


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Resear ch | C&T

FABACa, both keratins 1 and 10 were shown to be

down-regulated in skin treated with retinoic acid

in vitro and in vivo.20Interestingly, however, not all

dierentiation markers are regulated by retinoic acid;

involucrin, for example, is unaected when cultured

keratinocytes are treated by retinoic acid (see Page 46

for further discussion).

SCD1 and Anti-ac ne Poten tialAs noted previously, studies11point to a connec-

tion between SCD1 enzyme inhibition and ABCA1activation in skin; the deletion of SCD1 reduces

secretion of sebaceous lipids, which may be of value

in the treatment of acne. In relation, the indirect

inhibition of SCD1 activity by FABACs does not

appear to aect barrier integrity, unlike retinoic

acid. is is believed to be a result of the compensa-

tion mechanism. While inhibition of SCD1 leads

to an increase in ABCA1 transporter activity and

the depletion of barrier cholesterol levels in kerati-

nocytes, a compensatory enhanced production of

cholesterol and ceramides may lead to a replenished

barrier. is restored barr ier is especially necessary in

the case of reduced sebum secretion, which acts as aprotecting layer.

ere are numerous factors for the initiation and

progression of acne, and its severity can be related

to the interplay between these factors. Table 3 and

Figure3 summarize the physiological conditions

leading to acne and the anticipated activity of the

specied FABACabased on its structure, SARs with

similar FABACs, and data generated from the gene

expression study.

Practical Ap plica t ions e presented active has potential for anti-aging

and anti-acne applications, and the next steps are to

study its behavior in topical formulations and acquire

safety assessment data relevant to the skin. When

considering a compound for potential biological

activity, rst-tier studies should seek to understand

its mode of action (i.e., pharmacodynamics) and

site of action i.e., the skin sub-t issue and cellular,

receptor and enzyme levels. Based on this screening,

a hypothesis is drawn, which is the stage at which

the present authors have arrived and at which this

paper was written. Perhaps the most interesting

aspect is that FABACs impart biological activity

manifestations similar to those of a known drug butby aecting dierent cellular entities.

Table 3.Cond itions Leading to Acne and Anticipated Activity of the Spec ied FABAC

Abnormality in acne Clinical/physiological effectPotential FABAC activity to attenuate

the condition

Increased sebum productionas a result of elevated bloodhormone levels or otherabnormal physiology

Sebum serves as a nutrient,fostering bacterialproliferation in the gland

Potential SCD1 enzyme* inhibition,associated with:a) Depletion in sebum lipidsb) Attenuation in sebaceous gland activity

Abnormal microbiotapopulation, especiallyPropionobacterium acnes(P. acne)

P. acne consumes sebumand over-proliferates,resulting in the release ofinammatory fatty acids andtoxins

Due to its chemical properties, lipophilicityand relatively low MW, the FABAC mayintercalate into the bacterial wall, createimbalance and partial perturbation of thebarrier, and therefore decrease the bacteriapopulation

Cornication of thepilosebaceous duct thatnarrows the duct openingand restricts sebumdrainage

Obstruction of sebum owfrom the gland onto thesurface, therefore appropriatedrainage of the gland is notachieved

Attenuation of keratinocyte differentiationto corneocytes; relief of pore-clogging ofthe pilosebaceous opening, allowing moreeffective sebum drainage**

In

ammation

Humoral immune responseto free fatty acids andtoxins; recruitment of

in

ammatory immune cellsand biomarkers that leadsto skin damage and cancause scarring

Depletion in sebum lipid and potential

antimicrobial activity can lead to reductionin inammation

* Stearoyl CoA-Desaturase-1 (SCD-1) is an enzyme that catalyzes the synthesis of monounsaturated fatty acids from saturated fatty acids.

** Such an effect is claimed for both retinoic acid and salicylic acid


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Resear ch | C&T

Summary

Here, the authors present the potential activity ofa selected FABAC on skin. Initial in vitro screenings

are presented, leading to a hypothetical suggested

activity of the active. Based on screenings, SARs and

the ingredient's proposed mechanism of action, a

hypothesis for its activity as an anti-aging and anti-

acne active is drawn.

Interestingly, its suggested mechanism can be

compared to that of retinoic acid, but while retinoic

acid acts via the activation of nuclear receptors, the

FABAC is thought to act on a cellular membrane

transporter level and through competitive enzyme

inhibition. Lastly, this apparent ly milder yet eec-

tive mode of action could translate to larger safetymargins; when tested for cytotoxicity on a full thick-

ness model, the FABAC demonstrated no signicant

changes in cellular viability up to levels of 2%.

Acknowledgments: Ga lderm erapeutics, an Israeli star t-up company,

and Nava Dayan, PhD ([email protected]), collaborated on the

present work; the authors are thankful to Prof. Philip W. Wertz, from the

University of Iowa, for his critical review of this paper.

References 1. I Goldiner et al, ABCA1 dependent but apo A-1 independent

cholesterol efux mediated by fatty acid-bile acid conjugates

(FABA's), J Biochem 396 526-536 (2006)

2. J Nie, X Fu and W Han, Microenvironment-dependent homeo-

stasis and differentiation of epidermal basal undifferentiatedkeratinocytes and their clinical applications in skin repair, J Eur

Acad Dermatol Venereol 27(5) (2013) 531-535 (2013)

3. T Gilat et al, Fatty acid bile acid conjugates (FABACs) New

molecules for the prevention of cholesterol crystallization in bile,

Gut 48(1) 75-9 (Jan 2001)

4. T Gilat et al, Arachidyl amido cholanoic acid (Aramchol) is a

cholesterol solubilizer and prevents the formation of cholesterol

gallstones in inbred mice, Lipids 36(10) 1135-40 (Oct 2001)

5. US Pat 6384024B1, Bile salt conjugates, assigned to T Gilat

(May 7, 2002)

6. US Pat 6395722B2, Fatty acid derivatives of bile acids and bile

acid derivatives, assigned to T Gilat (May 28, 2002)

7. US Pat 6589946B2, Bile salt conjugates, assigned to T Gilat (Jul

8, 2003)

8. I Kravchenko, Y Boyko, N Novikova, A Egorova and S Andronati,

Inuence of cholesterol and its esters on skin penetration in vivo

and in vitro in rats and mice, Ukrainica Bioorganica Acta 1 (2011)

17-21

9. MR Prausnitz et al, Skin barrier and transdermal drug delivery,

available at drugdelivery.chbe.gatech.edu/Papers/2012/Praus-

nitz%20Derm%20Book%20Chapter%202012.pdf (Accessed

Mar 21, 2014)

10. CL Hedberg, PW Wertz and DT Downing, The nonpolar lipids of

pig epidermis, J Inves Derm 90 225229 (1988)

11. YJ Jiang, B Lu, PM Elias and KR Feingold, Regulation of ABCA1

expression in human keratinocytes and murine epidermis, J

Lipid Res 47 2248-2258 (2006)12. P Costet et al, Retinoic acid receptor-mediated iInduction of

ABCA1 in macrophages, Mol Cell Biol 23 (21) 7756-7766 (2003)

13. Ibid Ref 10

14. S Lambert, R Gniadecki, and Y Poumay, Cholesterol and lipid

rafts as regulators of signaling through the EGF receptor in

keratinocytes, Open Dermatology J 3 151-158 (2009)

15. LJ Pike, Lipid rafts, bringing order to chaos, J Lipid Res 44,

655-667 (Apr 2003)

16. F Sporl et al, Real-time monitoring of membrane cholesterol

reveals new insights into epidermal differentiation, J Invest Derm

130(5) 1268-1278 (2010)

17. RL Eckert and ER Rorke, Molecular biology of keratinocytes

differentiation, Environ Health Perspect 80 109-116 (1989)

18. Y Poumay, F Herphelin, P Smits, IY De Potter and MR Pittelkow,

High-cell density phorbol ester and retinoic acid upregulate

involucrin and downregulate suprabasal keratin 10 in autocrinecultures of human epidermal keratinocytes, Mol Cell Biol Res

Commun 2(2) 138-144 (1999)

19. C Fisher, M Blumberg and M Tomic-Conic, Retinoid receptors

and keratinocytes, Crit Rev Oral Biol Med 6(4) 284-296 (1995)

20. H Torma, Regulation of keratin expression by retinoids, Dermato-

Endocrinology 3:3 136-140 (2011)

Figure 3.Diagram desc ribing the hypothesis for FABAC anti-acne ac tivity

Affecting arachidonic

acid cascade

Attenuation in conversion

of saturated to mono

unsaturated fatty acids

Induction of changes

in sebum composition;

less wax diesters and

triglycerides

Reduction in

inammation

FABAC inhibits

SCD1 enzyme and

enhanced ABCA1

transporter activity

Reduction in sebaceous

gland activity

Activation of ABCA1

transporter

Down regulation of

keratin 1 and 10

Decrease in cornication

of the pilosebaceous

gland duct

Potential compensation

mechanism of RXR

activationPotential anti-microbial

effect

Reduction in p. acne

population A retinoic acid like

anti-acne effect


35/102

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Resear ch | C&T



F

ragrances have become ubiquitous in skin and hair care products

to appeal to the consumer's senses. However, fragrances have been

associated with allergic contact dermatitis in applications including:

unspecied leave-on products, sun tan lotion,1deodorants,2scented lotion,

unspecied rinse-oproducts, ne fragrances, shampoo, liquid soap, aer-

shave, lipstick, sunscreen, hair styling products, shaving foam, mascara, hair

dye, eye shadow and makeup cream. An example of typical allergic contact

dermatitis of the axilla due to a deodorant fragrance is shown in Figure 1.

While some dermatologists recommend avoiding all fragrances yielding

positive patch test results, as shown in Figure2, it has become increasingly

dicult to avoid all fragrances and in the end, may be unnecessary for the

patch test positive patient.

To identify dermatitis caused by fragrance, a patch test3for common

aromatic allergens was designed in which two fragrance mixes using

putative common allergens served as screens. Fragrance Mix#1 (FM1) was

developed from the fragrances used in an antifungal cream that had caused

an allergic contact dermatitis epidemic.4It comprised: Evernia prunastri

(oak moss), isoeugenol, cinnamyl alcohol, eugenol, cinnamal, geraniol,

-amylcinnamal and hydroxycitronellal. Fragrance Mix #2 (FM2), a later

attempt5to identify fragrance allergens, consisted of hydroxyisohexyl

3-cyclohexene carboxaldehyde (HICC), farnesol, citral, hexyl cinnamal,

citronellol and coumarin. ese materials are considered EU fragrance aller-

gens; Table 1 on Page 36 lists them with their FM designations, along with

additional EU fragrance allergens. ese mixes have been used in fragrance

allergy testing reported in the literature, which are reviewed here.

Prelim inary Questionnaire e diagnosis of a fragrance contact allergy always starts with a detailed

medical history. Schollhammer et al. developed a questionnaire to deter-

mine if consumers had a certain, probable or possibleallergy to fragrances

based on their recollection of adverse reactions to perfumes or perfumed

products.6In this questionnaire, the certainallergy included an itching

dermatitis reaction to at least one ne perfume or aershave, and reactions

to other perfumed products. e probableallergy involved reacting to

one or more perfumed products (e.g., deodorant) but no specic perfume

Howard I. Maibach, MD

University of California San Francisco, San Francisco, USAGarrett Coman and Nicholas Blickenstaff

University of California San Francisco, San Francisco, USA;

and University of Utah, Salt Lake City, USA

Ashley Edwards

Touro University, Vallejo, CA, USA

Is Fragrance-free Always Necessary?

Understanding Fragrance Allergy

GSBHSBODFBMMFSHZt QBUDI UFTUt VTFUFTUt SFQFBU

PQFOBQQMJDBUJPOUFTUt

EFSNBUJUJT

KEY WORDS

5I JTBSUJDMFSFWJFXTTUVEJFT

UPEJBHOPTFBMMFSHJD

DPOUBDUEFSNBUJUJTEVF

UPGSBHSBODFJODMVEJOH

BQBUDI UFTUEFTJHOFEUP

NFBTVSFTVDI -JNJUBUJPOTPGQBUDI UFTUJOHUI F

SFMFWBODFPGGSBHSBODF

DPODFOUSBUJPOJOQSPEVDUT

VTFUFTUJOHPGDPNNPO

DPOTVNFSQSPEVDUT

BOEEFSNBUPMPHJTU

SFDPNNFOEBUJPOTUP

NBOBHFGSBHSBODFDPOUBDU

BMMFSHZBMTPBSFEJTDVTTFE

ABSTRACT



37/102

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38/102


Resear ch | C&T

being identied as causing the clinical reaction. e

possibleallergy meant reacting to various cosmetic

products with and without perfume, where materials

other than fragrance constituted the possible cause

of the reaction. Finally, those identied without a

fragrance allergy had never reacted to a perfumed

material.

is questionnaire allows the dermatologist to

determine which patients have the highest probability

of fragrance contact allergy before patch testing. With

the proper clinical history, patients then proceedto the patch testing of FM1 and FM2, to dene the

possible role of fragrance in the dermatitis.

Patch TestingPatch testing is used by dermatologists to

determine if a chemical is causing an individual's

allergic inammatory reaction on the skin. Usually, a

sampling of diluted potential allergens is arranged in

a grid pattern on an individual's back. Since this test

is for a type IV hypersensitivity reaction, or delayed

type of hypersensitivity, the skin must be checked

two and four days later to assess for reaction, which iscontained to the area of application.

Testing with FM1 is a common practice when

dermatitis is suspected to be from fragrance. Nardelli

et al.3showed that 9.6% of patients investigated

for fragrance contact allergy reacted positively to

FM1, and 6% to FM2. Of those with suspected

fragrance induced dermatitis, sensitivity for FM1 has

been shown to be 27.2%, and 8.721.5% for FM2.7

Additional patch testing for FM2 helps to minimize

fragrance-induced clinical dermatitis false nega-

tives, with an estimated additional 6% of patients

identied.3

Additionally, Larsen et al. report false negativesto be 33%, suggesting neither FM1 or FM2 alone

are sucient screening tools.8Schnuch noted that

46% of patients react negatively when tested for the

individual constituents of FM1 but positively to the

mixture.9 is may be due to false positive reactions

to the mix, lowered allergen th reshold, false negative

Figure 2.Positive patch test reactionscored as ++ acco rding to International

Contact Dermatitis Research Group

recommendations

Photo Credit: Jean-Marie Lachapelle, MD

Figure 1.Typical allergic contac tderm atitis of the axilla due to a deodorant

fragrance No te: The fold o f the axilla

is partly spared ; a c lassic observation

believed to b e due to axillary sweating

diluting the allergen.

Photo Credit: Jean-Marie Lachapelle, MD

As IFRA has learnedm ore abo ut fragrances,

recommendedco ncentrations for

fragrance use co ntinueto dec rease.


39/102


reactions to individual constituents, or the existence

of a compound allergy.6

To increase sensitivity, Hesiterberg et al. recom-

mend using four screening markers: FM1, FM2,

M. pereirae (balsam of Peru) and HICC. Further, in

addition to the 14 fragrance allergens used in FM1

and FM2 for patch testing, they recommend testing

for 12 fragrance constituents, including: butylphe-

nyl methylpropional, Evernia furfuracea, linalool,

benzyl salicylate, benzyl alcohol, anise alcohol,

benzyl cinnamate, amylcinnamyl alcohol, limonene,alpha-isomethyl ionone, benzyl benzoate and methyl

2-octynoate.1Recently, additional allergens have

been commercialized, including hydroperoxides of

linalool, hydroperoxides of limonene and perfume

mix (Mx-08).10

Fragranc e Concentrat ionConsideration of fragrance concentration and its

impact on dermatitis adds another layer of complex-

ity when managing fragrance-allergic consumers.

e International Fragrance Research Association

(IFRA) publishes safe guidelines on fragrance use.

Based on research, the IFRA Code of Practice

includes 186 standards that either restrict or prohibit

the use of selected fragrance materials for all types

of applications. Producers of fragranced cosmetics

and household products are expected to comply with

IFRA standards.11

In addition to regulating specic fragrance

compounds, IFRA sets acceptable fragrance exposure

levels. Allowable concentrations are determined by

the quantitative risk assessment of factors such as

volume of use, dermal exposure, and structural alerts

for dermal sensitization. Broad categories organize

products by exposure level, including: Category 1

for lip products, toys and waxes for mechanical hairremoval; Category 2 for deodorants, antiperspirants

Market Intelligence

n . JOUFMBOBMZTU. FSFEJUI ) PMMJIBOOPUFTUI BUCFBVUZQSPEVDUTI BWJOHBTUSPOHGSBHSBODFDPNQPOFOUPGUFOI BWFBOFEHFJOUI FNBSLFUQMBDFBOEUI BURVBMJUZGSBHSBODFJTCFDPNJOHBEJTUJODUCSBOEJOHNBSLFS BOEUI BUZPVOHFSDPOTVNFSTOBNFTDFOUBTBUPQBUUSJCVUFXIFOTFMFDUJOHCBUI BOECPEZQSPEVDUT

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Resear ch | C&T

and fragranced bracel

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