Acne Vulgaris
Conditions
Keywords
acne vulgaris, dihydroartemisinin
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
Interventions
DHA 40mg tid for 90 days
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactLujuan GAO, MD, PhD
Outcome results
None listed