NCT07007078招募中1 期
A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Acne Vulgaris
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of acne severity by Investigator's Global Assessment (IGA)
研究概览
简要总结
The goal of this clinical trial is to learn if dihydroartemisinin (DHA) works to treat Acne Vulgaris in adults. The main question it aims to answer is:
• Does DHA improve the acne severity by at least one grade after treatment. Researchers will treat patients who are clinically diagnosed as Acne Vulgaris to see if DHA works to alleviate the symptoms of Acne Vulgaris.
Participants will:
- Take DHA every day for 3 months
- Visit the clinic once every month for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with acne vulgaris;
- •For female patients, no pregnancy plans within the next 6 months.
排除标准
- •Patients who have used sex hormones or other systemic medications for acne treatment within the past 3 months;
- •Patients who have used topical medications for acne within the past 2 weeks;
- •Pregnant or breastfeeding women;
- •Patients with known severe diseases of vital organs (e.g., heart, liver, kidney) or malignancies.
研究组 & 干预措施
DHA (dihydroartemisinin) Arm
Experimental
干预措施: dihydroartemisinin (Drug)
结局指标
主要结局
Improvement of acne severity by Investigator's Global Assessment (IGA)
时间窗: Before and immediately after 90-day treatment
Improvement of acne severity is considered clinically significant if a subject's IGA improves by at least one grade
次要结局
- Change of serum total testosterone from baseline to the end of treatment(Before and immediately after 90-day treatment)
- Change of Global Acne Grading System (GAGS) score from baseline to the end of treatment(Before and immediately after 90-day treatment)
- Change of inflammatory lesion count from baseline to the end of treatment(Before and immediately after 90-day treatment)
- Change of non-inflammatory lesion count from baseline to the end of treatment(Before and immediately after 90-day treatment)
- Number of participants who achieved an IGA score of 0 or 1 at the end of treatment(Before and immediately after 90-day treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Vitamin D Supplementation in AcneAcne VulgarisNCT06141330HITEC-Institute of Medical Sciences58
尚未招募
2 期
Effect of New Topical Preparation for Treatment of Acne VulgarisAcne VulgarisNCT05899699Mansoura University20
已完成
3 期
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne VulgarisAcne VulgarisNCT00663286Dow Pharmaceutical Sciences1,399
终止
2 期
Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.Acne VulgarisNCT03752242BioMimetix JV, LLC2
已完成
2 期
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic DermatitisAtopic DermatitisNCT04504279Forte Biosciences, Inc.154