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4‐n‐butylresorcinol dissolving microneedle patch for skin depigmentation: a randomized, double‐blind, placebo‐controlled trial
Author(s) -
Kim Suyong,
Yang Huisuk,
Kim Miroo,
Baek Ji Hwoon,
Kim So Jeong,
An Sang Mi,
Koh Jae Sook,
Seo Ransug,
Jung Hyungil
Publication year - 2016
Publication title -
journal of cosmetic dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.626
H-Index - 44
eISSN - 1473-2165
pISSN - 1473-2130
DOI - 10.1111/jocd.12178
Subject(s) - depigmentation , medicine , dermatology , patch test , placebo , transdermal , irritation , pharmacology , allergy , pathology , immunology , alternative medicine
Summary Background For effective skin depigmentation, the skin depigmentation agent must be delivered to melanocytes, where melanin is synthesized. Although dissolving microneedle ( DMN ) is one of the best transdermal drug delivery systems to deliver the active compound, no clinical trial has been conducted in terms of safety and efficacy. Objectives To assess the clinical efficacy and safety of a DMN patch that contained 4‐n‐butylresorcinol, a skin depigmentation agent. Methods In the safety assessment, 31 subjects were selected for primary skin irritation test using Frosch & Kligman's method and 50 women for the cumulative irritation test and sensitization potential test using a modification of the Shelanski–Shelanski method. In the efficacy assessment, the 4‐n‐butylresorcinol DMN patch was compared with a control ( DMN without 4‐n‐butylresorcinol) in our double‐blind, placebo‐controlled study with 45 subjects by measuring two parameters, the melanin index and individual typology angle value, during 8 weeks of administration. Results The 4‐n‐butylresorcinol DMN patch was shown to be safe based on the results of the safety assessment and was more than two times effective than the control patch. Conclusion The 4‐n‐butylresorcinol DMN patch was effective and safe for skin depigmentation through targeting melanocytes and could be a useful functional cosmetic product.