The Efficacy and Safety of the Topical Application of Poly-Gamma Glutamic Acid Hydrogel Nanoparticle-Based Fermented Extract of a Medicinal Plant Solution for Androgenetic Alopecia: A Randomized Double-Blinded Placebo-Controlled Clinical Trial; [안드로겐성 탈모증 환자에서 폴리감마 글루탐산 하이드로겔 나노입자에 포집한 혼합복합발효추출물 도포제의 임상시험]

초록

Background: Androgenetic alopecia (AGA) is the most common cause of hair loss in adults. Topical application of the fermented extract of medicinal plants promoted hair growth through stimulation of me telogen to anagen transition in a mouse model. However, controlled studies are necessary to evaluate the efficacy of the topical application of me fermented extract solution in humans. Objective: We aimed to assess the efficacy and safety of topical poly-gamma glutamic acid hydrogel nanoparticlebased fermented extract of a medicinal plant solution (PGA solution) in terms of the clinical improvements in patients with AGA. Methods: This 24-week, randomized, double-blinded, placebo-controlled, single-center clinical trial enrolled 50 patients wim AGA (36 men and 14 women); the participants were treated with either PGA solution or placebo twice daily for 24 weeks. Efficacy was evaluated by a phototrichogram (total hair count per 1 cm2), patient's subjective assessments, and investigator's subjective assessments of clinical improvements in overall hair regrowth. Any adverse reactions were reported during the study. Results: At week 24, compared with baseline, the PGA solution group showed a significantly increased hair density compared to the placebo group (7.24±2.52/cm2vs. 1.53±1.39/cm2, p<0.0001). The average hair density after 24 weeks was 129.90±23.04/cm2and 115.32±20.35/cm2in the PGA solution group and the placebo group, respectively. There was no adverse reaction over the 24-week period. Conclusion: PGA solution may provide a safe and effective adjunctive treatment for patients with AGA. © 2021 Korean Dermatological Association. All rights reserved.

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