A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation

November 2017 | Volume 16 | Issue 11 | Original Article | 1127 | Copyright © 2017

Monique J. Vanaman Wilson MD,a Isabela T. Jones MD,b Joanna Bolton MD,c Lisa Larsen DO,d Douglas C. Wu MD PhD,e and Mitchel P. Goldman MDe,f

aCalifornia Skin Institute, Sunnyvale, CA bMcLean Dermatology and Skincare Center, McLean, VA cAlliant Dermatology, The Villages, FL dWest Dermatology, San Diego, CA eGoldman, Butterwick, Groff, Fabi & Wu, Cosmetic Laser Dermatology, San Diego, CA fUniversity of California, San Diego, Department of Dermatology, San Diego, CA

Abstract

Purpose: Though hydroquinone (HQ) remains the gold standard for treatment of hyperpigmentation, concerns about its safety have prompted the development of HQ-free topical skin lightening systems. Objective: To compare the efficacy and tolerability of a new HQ-free system and a popular HQ-based system for the improvement of facial hyperpigmentation and photoaging in darker skin types. Methods: This investigator-blinded trial randomized 30 subjects of Fitzpatrick skin types III to VI with moderate to severe hyperpigmentation to a new 7-product HQ-free system or a 7-product HQ-based system for 12 weeks. At 4, 8, and 12 week follow-up visits, a blinded investigator assessed efficacy and tolerability using standardized scales. Subjects also performed a self-assessment at each visit. Summary: Both the HQ-free and HQ-based systems produced significant improvements in Overall Hyperpigmentation that were sustained through week 12 (P=0.008, 0.0003). The HQ-based system demonstrated better improvement in overall hyperpigmentation at weeks 4, 8, 12 (P=0.01, 0.001, 0.003, respectively). Mottled Pigmentation Area Severity Index (MoPASI) scores improved with both systems (P=0.02, 0.01), with no statistically significant differences between the two treatment groups. Subject-rated hyperpigmentation was not different between groups. Subjects reported significantly more discomfort with the HQ-free system at week 8 (P=0.02); otherwise, measures of irritation were the same between groups. All irritation was described as mild to moderate. At week 12, 100% of subjects in the HQ-free group and 92.3% of subjects in the HQ-based group were satisfied with their outcome. Conclusion: Both a new HQ-free skincare system and a widely-available HQ-based system improved hyperpigmentation in Fitzpatrick skin types III to VI. Though the HQ-based system produced greater improvement in hyperpigmentation when compared to the HQ-free system, there was no difference in MoPASI scores between the treatment groups. Subjects were satisfied with both treatments and reported only mild to moderate irritation using either system.

J Drugs Dermatol. 2017;16(11):1127-1132.

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INTRODUCTION

Abnormal pigmentation resulting from conditions such as photodamage, post-inflammatory hyperpigmentation (PIH) and melasma are common concerns of patients in an aesthetic practice. Hydroquinone (HQ) remains the gold standard in treatment of hyperpigmentation. Though it is highly efficacious, regulatory agencies worldwide have raised concern about the safety of hydroquinone.1 The ability of hydroquinone products to produce ochronosis is well-established, and often mitigated by limited use of the medication.2 While rats fed large amounts of oral hydroquinone developed tumors, human carcinogenicity has not been reported.3 Less serious, and more common, adverse events associated with the use of HQ are irritation and allergic contact dermatitis, limiting its utility in many patients. These concerns have spurred the development of HQ-free skin lightening products. An HQ-free skin lightening system containing a skin lightener designed to affect multiple pathways of melanogenesis and melanin distribution, has previously been shown to be as effective and tolerable as a HQ 4% cream-based system when used for 12 weeks.4,5 Another study demonstrated sustained efficacy and tolerability in subjects who used the system for 24 weeks.6 This skin lightening system worked by preventing stimulation of 

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