Extension Phase of a Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia
January 2024 | Volume 23 | Issue 1 | 1266 | Copyright © January 2024
Published online December 12, 2023
Jordan V. Wang MD MBE MBA FAADa, Sabrina G. Fabi MD FAADb, Deanne Mraz Robinson MD FAADc, Shirin Bajaj MDd, Roy G Geronemus MD FAADe, Michaela Bell BS MBAf, Tiffany Robison MS CCRCg, Alan D. Widgerow MBBCh(MD) MMed(MHS) FCS FACSh
aLaser & Skin Surgery Center of New York, New York, NY
bCosmetic Laser Dermatology, San Diego, CA
cPresident and Co-Founder, Modern Dermatology; Assistant Clinical Professor of Dermatology,
Yale New Haven Hospital; CMO Ideal Image, Westport, CT
dLaser & Skin Surgery Center of New York, New York, NY
eLaser & Skin Surgery Center of New York, New York, NY
fDirector, Clinical Studies Alastin, a Galderma company
gAlastin Skincare, Inc., a Galderma company, Carlsbad, CA
hGalderma, Carlsbad, CA; Division Chief, Research, Center for Tissue Engineering,
Professor of Plastic Surgery, University of California, Irvine, CA
Abstract
Background: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial.
Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks.
Results: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort.
Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement.
J Drugs Dermatol. 2024;23(1):1266-1270. doi:10.36849/JDD.7622
INTRODUCTION
Dyschromia continues to be a challenging cutaneous condition to treat, which has been complicated by the complex pathways involved and the nuances of individual cases. The sheer number and variety of potential triggers are vast, which mimic the nature of the signaling pathways and cellular interactions involved, especially those between melanocytes, keratinocytes, and endothelial cells. Recent gene expression and cellular studies using melanocytes, keratinocytes, and endothelial cells, as well as melanocyte production models, have identified novel topical agents that are active in the pigmentary pathways, including those pertaining to photodamage, post-inflammatory hyperpigmentation (PIH), and melasma.1 Many of these ingredients were more recently formulated into a novel topical product aimed at improving dyschromia without any limitations in long-term use.
