4-n-butylresorcinol dissolving microneedle patch for skin depigmentation: a randomized, double-blind, placebo-controlled trial.
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.


OBJECTIVE
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.


CONCLUSIONS
The 4-n-butylresorcinol DMN patch was effective and safe for skin depigmentation through targeting melanocytes and could be a useful functional cosmetic product.
Department of Biotechnology, Yonsei University, Seoul, Korea.
Suyong
S
Kim
Department of Biotechnology, Yonsei University, Seoul, Korea.
Huisuk
H
Yang
Department of Biotechnology, Yonsei University, Seoul, Korea.
Miroo
M
Kim
Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
Ji Hwoon
JH
Baek
Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
So Jeong
SJ
Kim
Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
Sang Mi
SM
An
Dermapro Skin Research Center, DERMAPRO LTD., Seoul, Korea.
Jae Sook
JS
Koh
Department of Airline Service, Hoseo University, Chungnam, Korea.
Ransug
R
Seo
Department of Biotechnology, Yonsei University, Seoul, Korea.
Hyungil
H
Jung
D000293:Adolescent; D000328:Adult; D000818:Animals; D017453:Dermatitis, Irritant / Q000209:etiology; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000009:adverse effects; D005260:Female; D006801:Humans; D007911:Lentigo / Q000188:drug therapy*; D008543:Melanins / Q000096:biosynthesis; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D012118:Resorcinols / Q000008:administration & dosage*; D012869:Skin Absorption; D062327:Skin Lightening Preparations / Q000008:administration & dosage*; D012880:Skin Pigmentation / Q000187:drug effects; D013552:Swine; D055815:Young Adult
C508220:4-n-butylresorcinol; D008543:Melanins; D012118:Resorcinols; D062327:Skin Lightening Preparations
depigmentation; dissolving microneedle; efficacy; safety