P8165Assessment of level of evidence for cosmeceutical use in dermatology

Romi Bloom, Northwestern University Feinberg School of Medicine, Departmentof Dermatology, Chicago, IL, United States; Antonella Tosti, MD, University ofMiami Miller School of Medicine, Department of Dermatology and CutaneousSurgery, Miami, FL, United States; Aurora Tedeschi, MD, PhD, University ofCatania, Dermatology Clinic, Catania, Italy; Dennis West, PhD, NorthwesternUniversity Feinberg School of Medicine, Department of Dermatology, Chicago,IL, United States; Giuseppe Micali, MD, University of Catania, DermatologyClinic, Catania, Italy; Nicole Larsen, Northwestern University Feinberg School ofMedicine, Department of Dermatology, Chicago, IL, United States

Background: The cosmeceutical market is constantly expanding. While cosmeceut-icals have both cosmetic and pharmaceutical effects, they are not regulated by theFood and Drug Administration. Consequently, cosmeceuticals might not undergorigorous testing whichmay result in misleading claims about their risks and benefits.Additionally, cosmeceuticals do not list active ingredients, but rather ingredients arelisted with respect to concentration.

Methods: A systematic PubMed search was conducted to identify published reportsof cosmeceutical agents for which the highest level of evidence (LOE) was assessedusing JAAD guidelines. The agents were categorized as follows: 11 antioxidants (eg,vitamins A/B/C/E, selenium, ubiquinone), 2 growth factors (GF) (eg, epidermal GFand transforming GF), 3 peptides (eg, signal, carrier, and neurotransmittermodulating peptides), 22 botanicals (eg, oatmeal, olive oil, grape seed), 3 hydroxyacids (HA) (eg, alpha/beta/poly HA) and 6 hypopigmenting agents (HPA) (eg,hydroquinone, aloesin, kojic acid).

Results: A total of 114 citations were selected to determine the LOE for the 47agents. For antioxidants, 33 LOE assessments were made for 11 agents, with thehighest LOE (Level IB) for retinoids and vitamin A derivatives, vitamin B, ubiquinone,idebenone, eicosapentaenoic acid and kinetin. For GF, 4 LOE assessments weremade for 2 agents, with the same LOE (Level III) for both epidermal and transformingGF. For peptides, 6 LOE assessments were made for 3 agents, with the highest LOE(Level IIA) for signal peptides. For botanicals, 53 LOE assessments were made for 22agents, with the highest LOE (Level IB) for grape seed, green tea, reservatrol, soyisoflavones, curcumin, arnica, and lycopene. For HA, 6 LOE assessments were madefor 3 agents, with the highest LOE (Level IB) for beta HA. For HPA, 16 LOEassessments were made for 6 agents, with the highest LOE (Level IB) for ellagic acid.

Conclusion: The LOE consisted of nonexperimental descriptive studies (Level III-32% of citations) and evidence from expert committee reports or opinions or clinicalexperience of respected authorities, or both (Level IV-33% of citations). The risk tobenefit ratio could be improved if a higher LOE were to be obtained allowingphysicians to more confidently recommend cosmeceuticals to patients.

AB14

cial support: None identified.

Commer

P8385Clinical evaluation of a topical treatment with ascorbyl tetraisopalmitatenanoencapsulated, retinol, and glycolic acid in photoaged human skin

Jayme de Oliveira Filho, MD, Universidade de S~ao Paulo, S~ao Paulo, Brazil;Carolina Holleben, Dermage Laboratories, Rio de Janeiro, Brazil; Neise Avelar,Dermage Laboratories, Rio de Janeiro, Brazil; Simone Ribeiro, MD, DermageLaboratories, Rio de Janeiro, Brazil

Cutaneous aging is a complex biologic phenomenon in which there are biochem-ical, morphologic, and functional changes that lead progressively to the onset ofclinical signs that characterize aging. With age there are changes. Advances in skinbiology have increased the understanding of skin homeostasis of this organ and itsaging process, leading to the development of treatments and techniques in order toprevent this mechanism and to rejuvenate the human body’s largest organ. Thisarticle presenting clinical studies supporting the use of topically applied vitamin Cnanoencapsulated, glycolic acid and retinol for treating photoaged skin. Onehundred percent of the 31 healthy female volunteers (35-58 years old) withactinically aged facial, neck, and forearm skin showed an improvement. The efficacyof traditional active at high concentrations for prevention and treatment ofphotodamaged skin were confirmed.

d by Dermage Laboratories.

Supporte

J AM ACAD DERMATOL

P8044Clinical evaluation of the efficacy and tolerance of a body gel inconjunction with laser hair removal on the legs

Amanda Dahl, L’Oreal Research & Innovation, Clark, NJ, United States; MargaritaYatskayer, L’Oreal Resaerch & Innovation, Clark, NJ, United States; Michael Gold,Tennessee Clinical Res. Center, Nashville, TN, United States; Nannan Chen,L’Oreal Reseach & Innovation, Clark, NJ, United States; Susana Raab, L’OrealResearch & Innovation, Clark, NJ, United States; Yevgeniy Krol, Skinceutical Inc,New York, NY, United States

Introduction: Laser hair removal is one of the most common aesthetic cosmeticprocedures performed worldwide. Dry skin is also a common dermatologic effectdue to the thermal effect of the laser procedure. This study was designed to test theefficacy and tolerance of a body gel containing Hydrovance, Hepes, Hyaluronic Acidand Vitamin B3 in females undergoing laser hair removal on the legs.

Methods: This randomized, double-blinded, 8-week clinical study included 22female subjects aged 18-56 with Fitzpatrick types I or II and normally shaved legstwice daily. Both legs were treated with a hair removal laser (Gentlemax Pro,Syneron Candela) at the start of the study and a second time at 4 weeks. The body geltest product was applied in a randomized manner to one leg; the other leg wastreated with a vehicle product. Subjects were evaluated for smoothness, dryness(flakiness), skin tone (evenness), radiance, texture and overall appearance atbaseline (before the first laser treatment), day 3, week 4 (before laser treatment)and at week 8. Additionally, subjects were evaluated at all the above time points forobjective and subjective tolerance as well as at immediate postlaser, postapplicationat the baseline and week 4 visits. Subject self- assessment questionnaires and digitalphotography were also included in the study.

Results: The results showed that both the test product and the vehiclewere effectivein improving the skin condition after 8 weeks of product use. However, for skintone, texture and overall appearance the test product showed better improvementthan the vehicle as early as week 4. For dryness and flaking, improvement wassimilar in both products showing statistical significance by week 8. Immediatelyafter the first laser treatment the test product was not statistically significantly worsein stinging and burning, unlike the vehicle treated leg that showed significantworsening in both these attributes. This suggests that the test product reduces bothstinging and burning immediately postlaser, postapplication.

d 100% by L’Oreal.

Supporte

P7634Clinical evaluation of the tolerance and efficacy of a topical tighteningtreatment in conjunction with a radiofrequency procedure

Margarita Yatskayer, L’Oreal USA, Clark, NJ, United States; Christian Oresajo,L’Oreal Research & Innovation, Clark, NJ, United States; David Goldberg, SkinLaser and Surgery Specialists of NY & NJ, Passaic, NJ, United States; NannanChen, L’Oreal Research & Innovation, Clark, NJ, United States; Susana Raab,L’Oreal Research & Innovation, Clark, NJ, United States; Theresa Chen, L’OrealResearch & Innovation, CLark, NJ, United States; Yevgeniy Krol, SkinceuticalsInc, New York, NY, United States

Purpose: The objective of this study was to demonstrate the efficacy and tolerabilityof a topical tightening treatment containing yeast extract, tripeptide, hydrolized riceprotein, microcrystalline cellulose and cellulose gum and LHA on skin laxity (loose,sagging skin) on the posterior back thigh/buttock after both sides have been treatedwith an established FDA approved device (Alma Accent XL).

Methods: 20 white female volunteers between the ages 18 to 65 years with mild tomoderate loss of laxity (loose, sagging skin) on both back thigh/buttocks and thosewho could not have a dramatic fluctuation in weight were enrolled in 8-weekdouble-blinded randomized clinical usage of tightening treatment on the backthighs/buttocks in conjunction with a radiofrequency treatment procedure.Volunteers applied the topical tightening treatment on the designated posteriorthigh/buttock twice per day. Other leg remained untreated. Baseline assessments bya dermatologist included lifting, evenness of skin tone, radiance, skin texture,firmness/tightness, and overall appearance using a 5 point visual scale. Objectiveand subjective irritation symptoms were assessed using a 5 point scale at baseline(pre- and post-laser post-application), Day 3 and Week 4 (pre- and post-laser post-application) andWeek 8. Measurements of both thighs, subjects weight and subjectsimages of each posterior thigh/buttock were also obtained at the Baseline visit andall follow up visits. Subjects received 2 radiofrequency treatments at Baseline andWeek 4. Volunteers completed self-assessment questionnaires at each study visit.

Results: Results demonstrated that the topical tightening treatment containing yeastextract, tripeptide, hydrolized rice protein, microcrystalline cellulose and cellulosegum and LHA showed significant improvements in all attributes assessed.Additionally, when compared, the area treated with the Tightening treatment afterthe radiofrequency procedure showed greater improvements than the area treatedwith the radiofrequency procedure alone in skin tone (evenness), radiance and skintexture after 4 and 8 weeks, and in firmness/tightness and overall appearance after 8weeks.

d 100% by L’Oreal.

Supporte

MAY 2014