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 acidloaded dissolving microneedle patch was evaluated in a doubleblind 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 acidloaded 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. R esum e OBJECTIF: Bien que le patch de microaiguilles a dissolution automatique charg e d'acide ascorbique ait et e d evelopp e pour am eliorer les effets anti-rides, une evaluation de l'efficacit e avec un groupe de contrôle n'a pas encore et e effectu ee. Dans cette etude, l'effet antirides d'un patch a microaiguilles a dissolution automatique charg e d'acide ascorbique a et e evalu e dans une etude clinique en double aveugle avec un groupe de contrôle. En outre, l'irritation de la peau et le potentiel de sensibilisation cumul es du patch de microaiguilles a dissolution automatique charg e d'acide ascorbique a et e effectu ee. M ETHODES: Vingt-trois sujets ont et e s electionn es pour l' evaluation de l'effet anti-rides dans une etude clinique en double aveugle. Les sujets ont et e divis es en deux groupes. Les sujets du Groupe 1 ont appliqu e un patch de microaiguilles a dissolution ...

CO(2) FL might be a very convenient and effective modality for treating IGH without significant side effects.

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