Efficacy of Dihydroartemisinin for Treating Acne Vulgaris

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorShanghai Zhongshan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically diagnosed with acne vulgaris;

For female patients, no pregnancy plans within the next 6 months.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • dihydroartemisinin

    Drug

    DHA 40mg tid for 90 days

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: DHA (dihydroartemisinin) ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Improvement of acne severity is considered clinically significant if a subject's IGA improves by at least one grade

Time frame
Before and immediately after 90-day treatment

Secondary outcomes

1

Change of Global Acne Grading System (GAGS) score from baseline to the end of treatment

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

Time frame
Before and immediately after 90-day treatment
2

Change of inflammatory lesion count from baseline to the end of treatment

Time frame
Before and immediately after 90-day treatment
3

Change of non-inflammatory lesion count from baseline to the end of treatment

Time frame
Before and immediately after 90-day treatment
4

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

Other outcomes

Sponsors and contacts

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