DEFINITION / COMPOSITION

SEBARYL® FL LS 9088 is a complex of biotechnologi-cal and synthetic origin, for oily skin and scalp with a seborrheic tendency.

Main components:1. Amino acids and sulfurated peptides (seboregulation).2. Vitamins B: niacinamide, biotin, panthenol (inhibition of

lipogenesis).3. Xanthic base: caffeine (inhibition of lipogenesis).4. Steroidic heterosides of botanical origin (anti-inflam-

matory and auto-emulsifier of sebaceous lipids in excess).5. Zinc salt (seboregulation).

MECHANISM OF ACTION

• The activity of sebaceous glands is modulated by psychic, nervous, neurovegetative and hereditary influences as well as related to lifestyle (worsening effect with overly strong detergent).• Sebaceous secretion is mainly controlled by sexual androgens (Fig. 2) in both men and women: testosterone, dehydroepiandrosterone, androstanediols.

These androgens become active at the level of sebaceous glands and hair follicles under the influence of enzymes; thus, testosterone, as soon as it enters into sebaceous cells, is transformed into dihydrotestosterone by a specific enzyme: 5α-reductase (demonstrated to be present in sebaceous glands).• The exaggeration of sebaceous secretion is linked to a higher sensitivity of the sebaceous gland to androgenic hormones.• Thanks to its constituents - lipotropic factors - SEBARYL® FL LS 9088 is a bioregulator of sebaceous secretion:- via decreased sebaceous lipogenesis,- via an anti-enzyme effect: inhibition of the 5α-reductase

activity.Consequently, SEBARYL® FL LS 9088 is a regulator of seba-ceous excretion.

SKIN BENEFITS

1. Regulator of sebaceous secretion and excretion.2. Cleansing, natural astringent and matifying effect on

skin and scalp.3. Improving the structure and the comfort of oily skin.4. Improving the structure of oily hair; giving strength and

balance.5. Anti-irritating effect.

COSMETIC USE

Skin care:- for oily or mixed skin type, having an acneic tendency,- for skin having a shiny, irritable aspect.Hair care:- for oily scalp, with a seborrheic tendency,- in case of seborrheic alopecia.

ORIGINALIT Y

SEBARYL® FL LS 9088 does not cause any reaction such as sebaceous hypersecretion or rebound effect.

DOSAGE / SOLUBILIT Y / MODE OF INCORPOR ATION

1. Dose of use: 3 to 5%.2. Solubility: soluble in water, soluble in diluted ethanol, insoluble in oils.3. Mode of incorporation: SEBARYL® FL LS 9088 is incor-porated below 50°C during processing or at room tempe-rature for cold processing.

ANALY TIC AL CHAR ACTERISTICS

1. Aspect: limpid pale yellow aqueous liquid with a weak odor.2. Specifications: upon request.

TOLER ANCE

Good.

EFFIC ACY

Test summaries overleaf.

STOR AGE

In its original packaging, at 15 - 25°C.

INCI NAME

Water (and) Niacinamide (and) Yeast Extract (and) Aesculus Hippocastanum (Horse Chestnut) Seed Extract (and) Ammonium Glycyrrhizate (and) Panthenol (and) Propylene Glycol (and) Zinc Gluconate (and) Caffeine (and) Biotin.

MANUFACTURER

Laboratoires Sérobiologiques, division de Cognis France.

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AIRSEBARYL® FL LS 9088

S E B O R E G U L A T O R

9088-801-180 © LABORATOIRES SÉROBIOLOGIQUES, DIVISION DE COGNIS FRANCE

Fig. 2 – Mode of action of testosterone on a sebaceous cell.© Doris Fanta

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Fig. 1 – Sebaceous glands, the target of SEBARYL® FL LS 9088: schema / microphotograph (SG = Sebaceous Gland).

SG

Acro-infundibulum Sebaceous excretion

Epidermis

Sebum

Germinativelayer

Pool of diffe-rentiated cells

Secretion of sebumInfra-infundibulum

Sebaceousglands Undifferentiated

cells

Medium dermis

Division de Cognis France

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LABORATOIRES SÉROBIOLOGIQUES, DIVISION DE COGNIS FRANCE - 3, RUE DE SEICHAMPS - BP40 - 54425 PULNOY (FRANCE) - FAX. (33) 3.83.29.98.65 - TEL. (33) 3.83.29.97.929088-801-180 © LABORATOIRES SÉROBIOLOGIQUES, DIVISION DE COGNIS FRANCE

EFFIC ACY TESTS

Aim Comparison of the efficacy of a hydrogel containing 5% SEBARYL® FL LS 9088 for the treatment of oily skin having seborrheic and acneic tenden-cies, versus placebo.ProtocolDouble blind clinical study in 25 volunteers following the summarized experimental protocol.

Results (Fig. 4 and 5)

ConclusionOnly the hydrogel containing 5% SEBARYL® FL LS 9088 showed a signi-ficant anti-seborrheic activity with a decrease of the amount of active sebaceous glands, and of the sebor-rheic flux. The placebo hydrogel did not have such an activity.

SEBOREGULATING EFFECT(CLINICAL STUDY)

10 healthy female or male volunteershyperseborrheic scalp and hair

D0: before treatmentLipometric measurement 2 hours after shampoo

Randomization RIGHT LEFT Placebo lotion Lotion containing 3% SEBARYL® FL LS 9088

D28: after 4 weeks of treatmentSame measurement as on D0

Measurement areas

Protocol

Results ConclusionA hair lotion containing 3% SEBARYL® FL LS 9088 showed a significant anti-seborrheic activity on the scalp after a 4 week treatment. In the same expe-rimental conditions, the placebo did not have such an effect.

ProtocolThe effect of SEBARYL® FL LS 9088 (1-10%) was evaluated on cultures of human fibroblasts containing 5α- reductase type I. The inhibition of 5α-reductase was evaluated by measuring testosterone (substrate of 5α-reductase) metabolized per µg DNA per hour.

Results (Fig. 6)

25 healthy female volunteers seborrheic skin on the face

bidaily randomized treatment 4 weeks

hemi-face5%

SEBARYL® FLLS 9088

D28

D0

hemi-faceplacebo

D0 + D28: Sebutape + image analysis(quantification of the anti-seborrheic activity)

Fig. 5 – Illustration of the anti-seborrheic activity of 5% SEBARYL® FL LS 9088 measured by image analysis on Sebutape, from one subject.

Fig. 3 – Schema of the experimental protocol.

Fig. 6 – Inhibition of 5α-reductase type I in human fibroblasts by SEBARYL® FL LS 9088.

Placebo hydrogel Hydrogel with 5%SEBARYL FL LS 9088

0

100

200

300

400

500

600

700

Amount of active sebaceous glands

D0 D28

Total amount of sebaceous spots detected onSebutape

- 4.2%(NS) - 16.6%

(*)

D0: before treatmentD28: after 4 weeks treatment

0

25

50

75

100

125

0 2 4 6 8 10

5 -reductase activity in % / untreated

SEBARYL FL LS 9088 in %

60 minutes

120 minutesStatistics:

Average ± SEM(*) very significant interval(p < 0.001) with the control(Student's t test)

IC50= 3.9%

α

(*)IC50 = 2.4%

(*)(*)

Fig. 7 – Schema of the experimental protocol.

Sebum level (µg/cm2)

- 31.7%(*)

- 20.7%(NS)

Statistics:Wilcoxon's T test(*) p = 0.0469(NS) not significantT SEM

D0D28

Placebo lotion Lotion containing 3%SEBARYL FL LS 9088

0

50

100

150

200

250

300

350

®

Fig. 8 – Evolution of the normal seborrheic level of the scalp, measured 2 hours after shampoo, after 4 weeks of treatment. Mean results from 10 subjects.

Statistics:Wilcoxon's T test(*) p = 0.05(NS) not significantT SEM 25 subjects

Seborrheic flux

Summarized surface of total sebaceous spotsdetected on Sebutape (mm2)

- 15.6%(NS) - 21.6%

(*)

Placebo hydrogel Hydrogel with 5%SEBARYL FL LS 9088

02468

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Fig. 4 – Anti-seborrheic activity of SEBARYL® FL LS 9088 quantified by image analysis on Sebutape. Evolution after a 4 week treatment of the amount of active sebaceous glands, and the quantity of excreted sebum. Mean results on 25 subjects.

D28D0

Placebo

5% SEBARYL® FL LS 9088

Many sebaceous spots of various sizes.

Decrease in the amount of small spotsbut persistence of a large seborrheic flux

appearing through spots of large size.

Many sebaceous spots of various sizes on the control lateral area.

Very clear decrease in the amount of sebaceous spots, being characteristic

of an anti-seborrheic activity.

INHIBITION OF 5α-REDUCTASE(IN VITRO)

ANTI-SEBORRHEIC ACTIVITY ON SCALP (CLINICAL STUDY)

D28D0

ConclusionSEBARYL® FL LS 9088 significantly inhibits 5α-reductase type I starting at a 5% dosage; this effect increases with the duration of the treatment.IC50 = 2.4% at 120 minutes.