Comparative Study of Hydroquinone-Free and Hydroquinone-Based Hyperpigmentation Regimens in Treating Facial Hyperpigmentation and Photoaging
March 2013 | Volume 12 | Issue 3 | Supplement | S32 | Copyright © 2013
Sabrina G. Fabi MD and Mitchel P. Goldman MD
Goldman, Butterwick, Fitzpatrick, Groff & Fabi, Cosmetic Laser Dermatology, San Diego, CA
BACKGROUND: Photoaged skin, characterized by mottled, irregular areas of pigmentation, is a common skin condition that is often difficult to treat. The areas of hypermelanosis are an aesthetic concern to subjects and may lead to social distress and quality of life issues. There are many commercial hyperpigmentation regimens marketed to lighten dark spots and improve overall skin dyschromia. However, data to support efficacy of such kits are often lacking.
OBJECTIVE: This investigator-blinded, randomized trial was conducted to compare a new hydroquinone (HQ)-free hyperpigmentation regimen against a leading HQ-based hyperpigmentation regimen for the treatment of facial hyperpigmentation and photoaging.
METHODS: Subjects with mottled pigmentation and photodamaged facial skin were randomized to treatment with either the new 4-product (HQ-free) SkinMedica® Hyperpigmentation System (SKM; SkinMedica, an Allergan Company, Carlsbad, CA) kit or the 7-product (HQ-containing) Obagi Nu-Derm System (OMP; Obagi Medical Products, Long Beach, CA) kit. Subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales at baseline and at weeks 4, 8, and 12. Standardized digital photographs were taken at baseline and week 12. Self-assessment questionnaires were completed at week 12.
RESULTS: Thirty-six female subjects (16: SKM; 20: OMP) completed the 12-week comparative study. Both hyperpigmentation regimens significantly reduced Overall Hyperpigmentation, Mottled Pigmentation Area and Severity Index (MoPASI), global photoaging, and sallowness at week 12 compared to baseline. Significant reductions in tactile roughness were seen with the OMP regimen at week 12. In these investigator-blinded assessments, there were no significant differences between treatment groups, nor was there a difference in global response to treatment. Investigator assessments of tolerability showed mean scores were mild or below for all parameters with both treatment regimens.
CONCLUSION: A new 4-product (HQ-free) regimen was shown to be as effective and tolerable as a 7-product (HQ-based) regimen in reducing facial hyperpigmentation and photoaging in females with mottled pigmentation and photodamaged facial skin.
J Drugs Dermatol. 2013;12(3 suppl 1):s32-s37.
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As humans age, irregular areas of facial hyperpigmentation, resulting from a combination of intrinsic aging and long-term exposure to ultraviolet light, become more common.1,2 While there is great variation in the color of human skin worldwide, a uniform or even facial skin color is considered a sign of health, attractiveness, and youthfulness, and is therefore aesthetically desirable.3,4 Hyperpigmentary skin disorders can cause emotional and psychological effects and a decreased quality of life.5,6 In our image-conscious society, affected individuals are increasingly requesting treatment for this aesthetic problem to improve appearance. Hydroquinone (HQ) has long been considered the gold standard for skin lighteners,7-9 despite a rather modest efficacy requiring several weeks of treatment before its depigmenting effects are readily seen. More recently, various regulatory agencies around the world, including the US Food and Drug Administration (FDA), have raised questions related to the safety of HQ.7-10 This has prompted efforts to develop options for alternative and HQ-free treatments for hyperpigmentation.
Overall treatment success for hyperpigmentation is best achieved by combining various agents that work at different stages of melanogenesis. Thus, providing patients with a comprehensive regimen that lightens existing hyperpigmentation, prevents new pigment formation, and minimizes stimulation by ultraviolet rays may further enhance overall treatment success.
A comprehensive and HQ-free hyperpigmentation regimen was developed to address these key areas, combining 4 products including a novel skin brightening complex, facial cleanser, tri-retinol 1.1%, and sunscreen. The present study compares this new 4-product HQ-free SkinMedica® Hyperpigmentation System (SKM; SkinMedica, an Allergan Company, Carlsbad, CA) regimen against a 7-product HQ-based Obagi Nu-Derm System (OMP; Obagi Medical Products, Long Beach, CA) regimen in the treatment of facial hyperpigmentation and photoaging.
This study was conducted using the same design as a recently published study where 2 HQ-based hyperpigmentation kits were shown to be equally effective in significantly improving mottled pigmentation and photodamage in females.11 However, to further explore the effects of this multimodality skin brightening complex, HQ was replaced with the skin brightening complex in the SKM regimen.