Clinical efficacy comparison of retinol versus retinoic acid as the finalstep of a chemical peel procedure

(Poster reference number 5232)Deborah Atkin, MD, Dermatology and Laser of Del Mar, Inc, Del Mar, CA, UnitedStates; Elizabeth Ho, SkinMedica, Inc, Carlsbad, CA, United States; Lora Colvan,SkinMedica, Inc, Carlsbad, CA, United States; Rahul Mehta, PhD, SkinMedica, Inc,Carlsbad, CA, United States; Sujatha Sonti, PhD, SkinMedica, Inc, Carlsbad, CA,United States

Retinol, although a less potent derivative of retinoic acid, has been shown to inducesimilar molecular and cellular changes within the skin, when applied topically at aconcentration of approximately 10 times higher than retinoic acid. Currently,compounded prescription retinoic acid is used as a third step in a commerciallyavailable, very superficial chemical peel treatment. The chemical peel treatmentconsists of a prepping solution (step 1), peeling solution (step 2), and retinoic acid(step 3). Apart from the inconvenience of obtaining compounded retinoic acid,variations in compounding and storage may occur, which could affect the consis-tency and predictability of the peel. To address this issue, a new retinol product wasdeveloped to replace the retinoic acid step in the chemical peel treatment. A single-center, bilateral split-face comparison study was conducted to compare thetolerability and efficacy of retinol versus retinoic acid when used with a series ofthree very superficial chemical peel treatments, in subjects with mild to moderatefacial photodamage. Nineteen female subjects, aged 18-65 years presenting withmild or moderate facial photodamage and Fitzpatrick skin types I-IV, completed the12-week study. At baseline, weeks 4 and 8, subjects were treated with steps 1 and 2of the chemical peel on the entire face, followed by a split-face application of retinolon the left facial side and retinoic acid on the right facial side. Investigator efficacyassessments for peeling, global photoaging, fine lines and wrinkles, and mottledpigmentation were conducted at baseline, weeks 4, 8, and 12. Investigator andsubject tolerability assessments for erythema, edema, frosting, burning/stinging,itching, and tightness, and standardized digital photography were conducted at allvisits. Overall facial side preference, as determined by the amount of peeling, wasalso assessed by the investigator and subject after each chemical peel treatment. Atall visits, there were no differences between the retinol and retinoic acid treatedfacial sides in efficacy and tolerability assessments and photographs. The amount ofpeeling was very similar between the two facial sides, with 95% of subjectsdemonstrating no differences. These results suggest the new retinol product mayprovide comparable tolerability and efficacy to retinoic acid, when used incombination with the very superficial chemical peel treatment. In addition, theretinol product would provide increased stability and consistency.

AB24

cial support: 100% paid for by SkinMedica, Inc.

Commer

Clinical efficacy evaluation of the skin lightening effects of multimodalityformulations in a UV-induced hyperpigmentation model

(Poster reference number 5282)Elizabeth Ho, SkinMedica, Inc, Carlsbad, CA, United States; Monya Sigler, PhD,Thomas J. Stephens and Associates, Inc, Carrollton, TX, United States; RahulMehta, PhD, SkinMedica, Inc, Carlsbad, CA, United States; Sujatha Sonti, PhD,SkinMedica, Inc, Carlsbad, CA, United States

Skin lightening preparations are used by people all over theworld for a diverse rangeof dermatologic indications. Hydroquinone is the criterion standard and remains theonly prescription product available in the United States for the treatment ofgeneralized facial hyperpigmentation. Irritation and the risk of exogenous ochro-nosis are the main adverse effects of concern. Therefore, there has been a constantsearch for developing new treatment alternatives. Understanding the molecularmechanisms involved in pigmentation allows us to develop a novel product that usesa multimodal treatment approach. We developed three proprietary formulas (SM1,SM2, and SM3) combining skin lightening agents that act via different mechanisms ofaction. The actives included 4-ethoxybenzaldehyde (an antiinflammatory and PGE2suppressor), licorice extract (tyrosinase inhibitor), THD ascorbate (antioxidant),niacinamide (melanosome transport inhibitor), ethyl linoleate tyrosinase inhbitor(enhances turnover of epidermis), hexyl resorcinol (antioxidant), and retinol(tyrosinase transcription inhibitor; enhances turnover of epidermis). A single-center, double-blind comparison study was conducted to compare the efficacy ofSM1, SM2, and SM3 in reducing UV-induced hyperpigmentation. Eighteen healthysubjects with Fitzpatrick skin types III completed the study. At baseline, five testareas were marked onto the backs of the subjects: untreated control, positivecontrol (hydroquinone 4%), SM1, SM2, and SM3. Assignments of the test products totest areas were randomized to avoid site bias. Test sites were irradiated with 1.0, 1.5,2.0, and 2.5 MEDs. After 2 days, to allow for pigmentation development, 30 �L ofeach test product were applied to the respective test sites by the study staff, oncedaily for 4 weeks (Monday through Saturday). Chromameter measurements (L*brightness) and standardized digital photography were taken twice a week of thetest sites. At the end of treatment, all three formulas demonstrated statisticallysignificant reductions in UV-induced hyperpigmentation compared to baseline (allP # .0001). SM1 and SM2 consistently provided greater increases in L* compared tothe positive control hydroquinone 4%. Results from this study indicate these topicalformulas which incorporate a multimodal approach to skin lightening may providean additional treatment option beyond hydroquinone for hyperpigmentation.

cial support: 100% paid for by SkinMedica, Inc.

Commer

J AM ACAD DERMATOL

Clinical evaluation of the effectiveness and tolerance of a topical wrinklefiller

(Poster reference number 5548)Amanda Dahl, L’Oreal Research & Innovation, Clark, NJ, United States; ChristianOresajo, L’Oreal Research & Innovation, Clark, NJ, United States; MargaritaYatskayer, L’Oreal Research & Innovation, Clark, NJ, United States

Background: There is a growing need for alternatives to invasive cosmetic surgeryprocedures for patients seeking safe and affordable facial rejuvenation. Injectablefillers have been shown to be excellent minimally invasive alternatives, andhyaluronic acid (HA) fillers are among the most efficacious and commonly useddermal fillers. Injectable fillers still pose health risks and are expensive; therefore,the need for at home and affordable topical wrinkle fillers for patients seeking similarresults to injectable treatments is crucial. The objective of this clinical study was toevaluate effectiveness and tolerance of a topical wrinkle filler containing two formsof HA: HA biospheres and fragmented HA when used twice daily throughout a 4-week test period.

Methods: Fifty-two (52) female subjects 43-65 years of age, 50% having self-perceived sensitive skin, moderate to severe wrinkles in the periocular area, andat least two of the following: nasolabial folds, brow furrow wrinkling, and/or frownlines/marionette lines were enrolled. Efficacy and tolerance were assessed atbaseline, immediate, 8 hours after the first application, and after 2 and 4 weeks ofproduct use. The objective tolerance grading was performed by a board-certifieddermatologist using a 4-point scale. Clinical assessments of facial skin wereperformed by an expert grader using a 10-point scale. Wrinkles in the perioculararea were further assessed using silicone replicas and facial appearance wasdocumented using digital photographs. Subject opinions of the wrinkle filler werecaptured using self-assessment questionnaires.

Results: After one application, the topical wrinkle filler demonstrated sustainedimprovement in skin lifting, plumpness, and frown lines/marionette lines assessed8 hours postapplication. After 4 weeks, improvements were found in all clinicallygraded attributes including coarse wrinkles in the periocular area, nasolabial fold,brow furrow, and frown lines/marionette lines. Silicone replicas showed statisticallysignificant improvements in total wrinkle area, length, and number of wrinkles after4 weeks. This study demonstrated that the topical wrinkle filler containing HAbiospheres and fragmented HA was well tolerated by the study panel and signifi-cantly improved moderate to severe wrinkles and facial skin appearance immedi-ately after one application, after 8 hours, and throughout the 4-week test period.

cial support: 100% is sponsored by L’Oreal Research & Innovati

Commer on.

Combination of deep nonablative radiofrequency with fractional RF skinresurfacing for the treatment of deep wrinkles and atrophic acne scars

(Poster reference number 4862)Monica Elman, MD, Beit Harofeim, Holon, Israel

Background: Effective treatment for deep wrinkles or atrophic acne scars requirestreatment of both epidermis (for epidermal roughness and hyperpigmentation) anddermis (for collagen remodeling). All first-generation radiofrequency systems allownonablative RF treatment while a few others allow simple bipolar fractional RF skinresurfacing. A novel FDA cleared therapy system (EndyMed PRO; EndyMed Ltd.,Cesarea, Israel) allows for the first time phase controlled multisource RF for bothdeep (11-mm) nonablative RF and fractional RF skin resurfacing on the sametreatment device.

Methods: Ten subjects with deep facial wrinkles and 10 subjects with atrophic acnescars were enrolled in the study. Patients were photographed using standardizedmethods. In each treatment session, each patient received a full face 3DEEPnonablative skin tightening treatment followed by a Fractional skin resurfacingtreatment. The treatment session were repeated once a month for a total of 3treatments.

Results: All subjects experienced mild to moderate edema and erythema as animmediate response to treatment. Edema resolved after up to 3 hours posttreat-ment, and erythema lasted up to 2 days. Microablative crusts lasted up to 5 days onfacial areas. Patient photographs before, after 4 weeks, and after 8 weeks weregraded according to the accepted Cosmetic Improvement Scale. Eighty-five percentof patients had good to excellent improvement 1 month after the third treatmentsession.

Conclusion: The presented results describe for the first time a new treatment system(EndyMed PRO that allows both deep nonablative RF delivery and fractional skinresurfacing on the same treatment platform.

cial support: None identified.

Commer

APRIL 2012