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Evaluation of the anti‐wrinkle effect of an ascorbic acid‐loaded dissolving microneedle patch via a double‐blind, placebo‐controlled clinical study
Author(s) -
Lee C.,
Yang H.,
Kim S.,
Kim M.,
Kang H.,
Kim N.,
An S.,
Koh J.,
Jung H.
Publication year - 2016
Publication title -
international journal of cosmetic science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.532
H-Index - 62
eISSN - 1468-2494
pISSN - 0142-5463
DOI - 10.1111/ics.12299
Subject(s) - ascorbic acid , irritation , wrinkle , chemistry , dermatology , placebo , medicine , sensitization , skin irritation , surgery , pathology , food science , immunology , gerontology , alternative medicine
Objective Although an ascorbic acid‐loaded dissolving microneedle patch has been developed to improve anti‐wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti‐wrinkle effect of an ascorbic acid‐loaded dissolving microneedle patch was evaluated in a double‐blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid‐loaded dissolving microneedle patch was performed. Methods Twenty‐three subjects were selected for anti‐wrinkle effect evaluation in a double‐blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid‐loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid‐loaded dissolving microneedle patch and control sample were evaluated. Results Skin treated with the ascorbic acid‐loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values ( P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement ( P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid‐loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization. Conclusions An ascorbic acid‐loaded dissolving microneedle patch produced a significant anti‐wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti‐wrinkle cosmetic field with patient convenience.