Clinical Evaluation of a 4% Hydroquinone + 1% Retinol Treatment Regimen for Improving Melasma and Photodamage in Fitzpatrick Skin Types III-VI

November 2016 | Volume 15 | Issue 11 | Original Article | 1435 | Copyright © 2016

Marta I. Rendon MD FAADa and Sylvia Barkovic BAb

aThe Rendon Center for Dermatology & Aesthetic Medicine and Skin Care Research Inc, Boca Raton, FL bResearch and Development,Valeant Pharmaceuticals North America LLC, Irvine, CA

Abstract

The bene ts of monotherapy with hydroquinone for melasma and retinoids for photodamaged skin is well established. Here we report results of a hydroquinone skincare regimen designed for melasma treatment combined with a cosmetic retinol cream on subjects presenting with both melasma and facial photodamage in a 24-week study. Improvement in melasma and photodamage ef cacy pa- rameters of melasma pigmentation intensity and melasma area and severity index (MASI), as well as overall photodamage and mottled hyperpigmentation were found by week 4, the rst post-baseline time point. By week 8 signi cant improvements were also found in melasma disease severity assessment, tactile roughness, ne wrinkles, crepiness, actinic lentigines, and laxity. By week 18 signi cant reduction in coarse wrinkles was evident. Bene ts persisted through the study end on the panel of 31 subjects, with over 3⁄4 of par- ticipants demonstrating improvements in 10 of the 11 graded attributes. For the remaining attribute, coarse wrinkling, approximately 50% of the panel showed improvement. The regimen produced an average of “marked improvement” in melasma severity (51-75% improvement). Results of tolerance evaluations documented overall treatment mildness for a majority of the study participants. Subject questionnaires concur with high ratings of the study regimen for tolerability, ef cacy perception, product aesthetics and overall treat- ment satisfaction in subjects of Fitzpatrick Skin Type III-VI classi cation with melasma and photodamage in mild-to-moderate severity. J Drugs Dermatol. 2016;15(11):1435-1441.

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Introduction

Hyperpigmentation disorders, including melasma, are common, particularly in women,1-3 among people with darker complexions (Fitzpatrick skin types IV-VI), and especially those living in areas of intense ultraviolet (UV) radiation such as Hispanics (especially of Caribbean origin), Asians and African Americans.4-9 Melasma is not uncommon in the United States (US). In a study of 2000 dermatology patients of black origin in Washington, pigmentary problems other than vitiligo were the third most commonly-cited skin disorder.10 Among a Latino population in Dallas, prevalence of melasma was 8.8%, and 4.0% of respondents reported a previous occurrence.11 A questionnaire sent to an Arab population resident in Detroit identified a 14.5% incidence of melasma and 56.4% complained primarily of alterations in skin tone.12 It has been estimated that 50% to 70% of pregnant women in the US develop melasma.13Melasma can also lead to decreased socializing, diminished self-esteem and lower productivity, due to its psychosocial impact.14-16 Treatment can have a positive impact on quality of life.17 It is not uncommon for patients with melasma to exhibit symptoms of facial photodamage such as mottled hyperpigmentation, lentigines, fine and coarse wrinkling, tactile roughness and elastosis, and it would be advantageous to provide a skin care system that addresses both.18-21Monotherapy with hydroquinone (HQ) has been used to treat hyperpigmentation for more than 50 years. HQ is considered the gold standard. While controversy exists regarding the longterm safety of HQ, its efficacy in treating melasma, both alone and in combination with other agents is well established.22 Pigment lightening by HQ becomes evident after 5–7weeks of treatment and common adverse events (AEs) include erythema and burning.23Topical retinoids have also been shown to be effective in melasma treatment,24,25 and as well as reducing many of the clinical manifestations of photodamaged skin.26 Treatment related AEs include retinoid dermatitis characterized by burning or stinging, erythema, scaling and dry skin. Unfortunately, monotherapy, whether HQ or retinoid, can require significant treatment duration before meaningful results are evident.27 As a result, coupled with various AEs when high concentrations are applied, combination therapies have become popular.

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