A Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia

April 2023 | Volume 22 | Issue 4 | 333 | Copyright © April 2023


Published online March 1, 2023

Jordan V. Wang MBE MBAa, Sabrina G. Fabi MDb, Deanne Mraz Robinson MDc, Shirin Bajaj MDa, Roy G. Geronemus MDa, Michaela Bell BS MBAd, Alan D. Widgerow MBBCh MMedd

aLaser & Skin Surgery Center of New York, New York, NY
bCosmetic Laser Dermatology, San Diego, CA
cModern Dermatology, Westport, CT
dAlastin, a Galderma company, Carlsbad, CA

Abstract
Background: Dyschromia can be caused by abnormalities in the increased production and/or reduced clearance of pigmentation in the skin. Causes of hyperpigmentation include excessive sun exposure, medications, hormones, post-inflammatory hyperpigmentation (PIH), and medical disorders, such as melasma. A novel topical product was recently developed, which contains actives that have been validated through in vitro studies to counteract various steps in the pigmentation pathways, including photodamage, PIH, and melasma. This study evaluates the safety and efficacy of this product for facial dyschromia.
Study Design: Subjects with mild to severe facial dyschromia were enrolled to receive either the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) or hydroquinone 4% topical to apply twice daily. Both cohorts received cleanser, sunscreen, and moisturizer. Follow-up occurred at weeks 4, 8, and 12. Blinded investigators used the modified Melasma Area Severity Index (mMASI) and modified Griffiths scales at baseline and final follow-up. Tolerability assessments and subject questionnaires were completed.
Results: Forty-three subjects were enrolled and randomized to either the novel topical product (n=22) or hydroquinone 4% (n=21) cohort. At week 12 follow-up, subjects using the novel topical product had significant improvements in mMASI scores for the right cheek (P=0.0097), left cheek (P=0.0123), combined cheeks (P=0.0019), and total facial area (P=0.0046). In contrast, subjects using hydroquinone 4% had no significant improvements in any of these areas. Although both cohorts demonstrated improvements in dyschromia and skin tone, the novel topical product also offered significant improvements in skin radiance (P=0.0015) and skin texture (P=0.0058), which the hydroquinone 4% cohort did not demonstrate. The hydroquinone 4% cohort experienced 5 adverse events, while there were no adverse events associated with the novel topical product. Subjects in the hydroquinone 4% cohort also more frequently experienced burning/stinging, tingling, itching, erythema, and dryness.
Conclusion: A novel topical product with PATH-3 Technology, designed to counteract various steps in pigmentation pathways, has been demonstrated to be safe and effective in treating facial dyschromia.

Citation: Wang JV, Fabi SG, Mraz Robinson D, et al. A multi-center, randomized, blinded clinical study evaluating the efficacy and safety of a novel topical product for facial dyschromia. J Drugs Dermatol. 2023;22(4):333-338. doi:10.36849/JDD.7340

INTRODUCTION

When considering treatment strategies and formulations that can target hyperpigmentation, two major challenges exist. Firstly, the causes, triggers, and pathways involved are multifaceted and plentiful. Not all pigmentary conditions are the same, nor do they always respond similarly between conditions and patients. There are many associated factors. This has likely contributed to the ongoing need for newer clinical research over the years as our field continues to search for effective treatment strategies. Secondly, multiple cell lines are involved in the process. A large portion of research and relevant treatment targets have traditionally been focused on melanocytes, as well as the pathways and products surrounding them. However, there is more to the story than simply melanocyte activation, melanin transfer and uptake, and melanin breakdown.

Some common triggers of dyschromia involve photodamage, aging, acne, inflammation, and hormones. These can influence various signaling pathways and cellular interactions, including those between melanocytes, keratinocytes, and endothelial cells. Although the melanocyte has been the focus of pigment targeting for many years (predominantly via tyrosinase enzyme), it has become more recently apparent that the keratinocyte is intricately associated with the melanocyte, particularly relating to inflammatory mediators (eg, plasmin, arachidonic acid,
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