Efficacy of Dihydroartemisinin for Treating Acne Vulgaris

Early Phase 1

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: dihydroartemisinin

• Registration Number: NCT07007078
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinically diagnosed with acne vulgaris;
• For female patients, no pregnancy plans within the next 6 months.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DHA (dihydroartemisinin) Arm	dihydroartemisinin	-

Primary Outcome Measures

Name	Time	Method
Improvement of acne severity by Investigator's Global Assessment (IGA)	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

Secondary Outcome Measures

Name	Time	Method
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	An improvement of ≥30% in the GAGS score will be considered significant
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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China