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临床试验/NCT05073211
NCT05073211已完成不适用

A Randomized Split-face Study of Photodynamic Therapy With St. John's Wort Versus Indole-3-acetic Acid for the Treatment of Acne

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
acne lesions

研究概览

简要总结

The investigators aimed to evaluated the efficacy and safety of SJW-PDT compared to indole-3-acetic acid (IAA)-PDT in the treatment of acne. The investigators also investigated the skin rejuvenating effects of SJW-PDT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients with mild to moderate facial acne
  • •between 25 and 60 years old

排除标准

  • •history of oral retinoid treatment with the past 6 months
  • •history of oral antibiotics, topical acne treatment, or skin rejuvenation treatment such as lasers and chemical peeling within the month before the start of the study

研究组 & 干预措施

IAA-PDT

Active Comparator

Participants were randomized to receive either the SJW extract or IAA on each split-face. The SJW extract (DR-Light complexTM; Genicos Co., Ltd, Cheongju, Korea) consisted of 70% 1, 3-butylene glycol, and 0.1% hypericin as active ingredients. After cleansing the face gently, participants applied 1.5 ml of 0.5% SJW extract on one half of the face and 1.5 ml of 0.015% IAA (AC gel®; Wellskin, Seoul, Korea) on the other half of the face for 10 minutes under occlusion.

干预措施: PDT (Procedure)

SJW-PDT

Experimental

Participants were randomized to receive either the SJW extract or IAA on each split-face. The SJW extract (DR-Light complexTM; Genicos Co., Ltd, Cheongju, Korea) consisted of 70% 1, 3-butylene glycol, and 0.1% hypericin as active ingredients. After cleansing the face gently, participants applied 1.5 ml of 0.5% SJW extract on one half of the face and 1.5 ml of 0.015% IAA (AC gel®; Wellskin, Seoul, Korea) on the other half of the face for 10 minutes under occlusion.

干预措施: PDT (Procedure)

结局指标

主要结局

acne lesions

时间窗: 1 and 4 weeks after the last treatment

change in the number of acne lesions after the treatment

次要结局

  • sebum secretion rate (μg/cm2)(1 and 4 weeks after the last treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Won Shin

Associate Professor

Seoul National University Bundang Hospital

研究点 (1)

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