Safety and Efficacy of a Novel Multimodality Hydroquinone-Free Skin Brightener Over Six Months
March 2013 | Volume 12 | Issue 3 | Supplement | S27 | Copyright © 2013
Suzanne Bruce MD
The Center for Skin Research, Houston, TX
BACKGROUND: Abnormal accumulation of melanin is a common aesthetic skin concern. For years, the gold standard for the treatment of hyperpigmentary disorders has been 4% hydroquinone (HQ). Due to regulatory agencies around the world questioning the safety of HQ, there has been interest in developing new HQ-free skin brightening/lightening products. A multimodality product (skin brightening complex) addressing various pathways for melanogenesis was developed as an alternative to HQ.
OBJECTIVE: The skin brightening complex was studied for efficacy and tolerability in subjects with moderate to severe facial hyperpigmentation.
METHODS: Subjects were instructed to apply skin brightening complex to the entire face twice daily and to follow a standard skin care regimen (facial cleanser, moisturizer, and sunscreen) during the course of the study. The study was conducted over a 12-week period and consisted of evaluation visits at baseline and at weeks 4, 8, and 12. At each visit, subjects were evaluated by an investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs and spectrophotometric assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. To assess longer-term safety and efficacy, 10 subjects elected to continue treatment for an additional 12 weeks (24 weeks total), with evaluations at weeks 18 and 24.
RESULTS: Twenty-six subjects completed the 12-week study, and 8 subjects completed treatment for an additional 12 weeks (24 weeks in total). In the 12-week study, the skin brightening complex was shown to be effective and significantly improved Overall Hyperpigmentation at weeks 4, 8, and 12 compared with baseline. The skin brightening complex also significantly improved the Mottled Pigmentation Area and Severity Index ([MoPASI], a modified Melasma Area and Severity Index [MASI] scale) at weeks 8 and 12 compared with baseline. These efficacy benefits continued at 24 weeks. The product was well tolerated at all evaluation visits. Subject questionnaires showed 80% or more of the subjects reporting pigmentation improvement and satisfaction with the skin brightening complex at all evaluation visits.
CONCLUSION: This HQ-free skin brightening complex was effective and well tolerated in subjects with facial hyperpigmentation who were treated for as long as 24 weeks.
J Drugs Dermatol. 2013;12(3 suppl 1):s27-s31.
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Melanin is an inert polymer pigment produced by the melanosomes, and it determines the color and gradation of skin.1,2 Skin tone and the uniformity or evenness of skin color are important cosmetic concerns throughout the world. Hyperpigmentary disorders of the skin are commonly seen in dermatology practices. Both sexes and all Fitzpatrick skin types are susceptible to these aesthetic skin conditions. Such hypermelanotic disorders typically result from advancing age, hormonal imbalance (changes that may be caused by pregnancy or use of contraceptives), and/or injury. Exposure to ultraviolet light (which produces inflammation and resultant cellular damage) is the most common cause of skin hyperpigmentation.3,4
The gold standard for skin lightening was hydroquinone (HQ) until regulatory agencies in Europe, Japan, and most recently in the United States questioned the safety of this agent.5-8 While the drug has been used as a skin lightener for over 50 years without evidence of human cancers,6 studies in rodents have produced renal tubule adenomas in male F-344 rats and liver adenomas and thyroid gland follicular cell hyperplasia in mice.9
Many currently available skin lightening agents (including HQ, arbutin, kojic acid, and others) act via inhibition of tyrosinase, the key enzyme involved in melanin production. However, tyrosinase is not the only pathway of interest for skin lightening ingredients. With an improved understanding of the complexities of melanogenesis, several other pathways are being pursued as targets for skin lightening agents. Rationally designed combination products can target several pathways to disrupt melanin.
Previously, a unique formulation containing several ingredients that address multiple pathways involved in melanin production and control was tested against the gold standard, 4% HQ, in subjects with moderate to severe facial hyperpigmentation. This HQ-free formulation was shown to be as effective and well tolerated as 4% HQ in a randomized, double-blind, half-face model.10 The present study was performed to gain additional safety and efficacy data on the skin brightening complex from an additional study site and also to assess long-term treatment effects.
MATERIALS AND METHODS
The criteria for participation in this study included subjects with Fitzpatrick skin types I to IV in good general health between the ages of 18 and 65 years with moderate to severe facial hyperpigmentation as determined by clinical examination. Subjects were required to have a baseline score of 4 to 9