4-n-butylresorcinol dissolving microneedle patch for skin depigmentation

a randomized, double-blind, placebo-controlled trial

Suyong Kim, Huisuk Yang, Miroo Kim, Ji Hwoon Baek, So Jeong Kim, Sang Mi An, Jae Sook Koh, Ransug Seo, Hyungil Jung

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)16-23
Number of pages8
JournalJournal of Cosmetic Dermatology
DOIs
Publication statusPublished - 2016 Mar 1

Fingerprint

Placebos
Skin
Safety
Melanocytes
Melanins
Drug Delivery Systems
Skin Tests
Cosmetics
4-n-butylresorcinol
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

Kim, Suyong ; Yang, Huisuk ; Kim, Miroo ; Baek, Ji Hwoon ; Kim, So Jeong ; An, Sang Mi ; Koh, Jae Sook ; Seo, Ransug ; Jung, Hyungil. / 4-n-butylresorcinol dissolving microneedle patch for skin depigmentation : a randomized, double-blind, placebo-controlled trial. In: Journal of Cosmetic Dermatology. 2016 ; pp. 16-23.
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abstract = "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.",
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4-n-butylresorcinol dissolving microneedle patch for skin depigmentation : a randomized, double-blind, placebo-controlled trial. / Kim, Suyong; Yang, Huisuk; Kim, Miroo; Baek, Ji Hwoon; Kim, So Jeong; An, Sang Mi; Koh, Jae Sook; Seo, Ransug; Jung, Hyungil.

In: Journal of Cosmetic Dermatology, 01.03.2016, p. 16-23.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 4-n-butylresorcinol dissolving microneedle patch for skin depigmentation

T2 - a randomized, double-blind, placebo-controlled trial

AU - Kim, Suyong

AU - Yang, Huisuk

AU - Kim, Miroo

AU - Baek, Ji Hwoon

AU - Kim, So Jeong

AU - An, Sang Mi

AU - Koh, Jae Sook

AU - Seo, Ransug

AU - Jung, Hyungil

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

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