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Recruiting NCT07007078

Efficacy of Dihydroartemisinin for Treating Acne Vulgaris

Early Phase I Interventional Acne Vulgaris

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dihydroartemisinin.
Who it may be relevant to
Registry conditions: Acne Vulgaris. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Acne Vulgaris

Overview

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

Interventions

  • Drug dihydroartemisinin
    DHA 40mg tid for 90 days

Primary outcome measures

  • Improvement of acne severity by Investigator's Global Assessment (IGA) [Time frame: Before and immediately after 90-day treatment]
Secondary outcome measures (5)
  • Change of Global Acne Grading System (GAGS) score from baseline to the end of treatment [Time frame: Before and immediately after 90-day treatment]
  • Change of inflammatory lesion count from baseline to the end of treatment [Time frame: Before and immediately after 90-day treatment]
  • Change of non-inflammatory lesion count from baseline to the end of treatment [Time frame: Before and immediately after 90-day treatment]
  • Number of participants who achieved an IGA score of 0 or 1 at the end of treatment [Time frame: Before and immediately after 90-day treatment]
  • Change of serum total testosterone from baseline to the end of treatment [Time frame: Before and immediately after 90-day treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT07007078 · B2025-113R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗