Efficacy of Dihydroartemisinin for Treating Acne Vulgaris

NCT07007078 | Recruiting Early Phase 1

• 1 other identifier: B2025-113R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Keywords

acne vulgaris; dihydroartemisinin

Outcome Measures

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

  Before and immediately after 90-day treatment

Secondary Outcomes (5)

• 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

• Change of serum total testosterone from baseline to the end of treatment

  Before and immediately after 90-day treatment

Study Arms (1)

DHA (dihydroartemisinin) Arm

EXPERIMENTAL

Drug: dihydroartemisinin

Interventions

dihydroartemisinin DRUG

DHA 40mg tid for 90 days

DHA (dihydroartemisinin) Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

artenimol

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Jingjing JIANG, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lujuan GAO, MD, PhD

CONTACT

86-021-64041990; gao.lujuan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication
• Access Criteria: IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).

Locations

CN (1)