Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

NCT07012486 | Recruiting Early Phase 1

• 1 other identifier: B2025-112R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if dihydroartemisinin (DHA) works to treat Androgenetic Alopecia (AGA) in female adults. The main question it aims to answer is:

• Does DHA increase terminal hair follicles in the vertex area. Researchers will compare oral DHA plus topical minoxidil to topical minoxidil alone in female patients with AGA to see if DHA works to alleviate AGA. Participants will:
• Receive oral DHA every day plus topical minoxidil or use topical minoxidil alone for 6 months.
• Visit the clinic once every month for checkups and tests.

Conditions

Androgenetic Alopecia (AGA)

Keywords

androgenetic alopecia; dihydroartemisinin

Outcome Measures

Primary Outcomes (1)

• Improvement in terminal hair follicles in the vertex area

  Terminal hair follicles in the vertex area will be quantified before and at the end of treatment

  Baseline and 180-day of treatment

Secondary Outcomes (5)

• Change of terminal hair follicle density in the vertex area from baseline to the end of treatment

  Baseline and 180-day of treatment

• Change of hair density in the vertex area from baseline to the end of treatment

  Baseline and 180-day of treatment

• Change of terminal hair follicle density in the frontal area from baseline to the end of treatment

  Baseline and 180-day of treatment

• Change of hair density in the frontal area from baseline to the end of treatment

  Baseline and 180-day of treatment

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

  Baseline and 180-day of treatment

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

oral dihydroartemisinin (DHA) combined with topical minoxidil

Drug: Oral DHA + Topical minoxidil 5%

Control Arm

OTHER

topical minoxidil alone

Drug: Topical Minoxidil 5%

Interventions

Oral DHA + Topical minoxidil 5% DRUG

DHA 20mg tid po plus daily topical minoxidil 5% for 180 days

Intervention Arm

Topical Minoxidil 5% DRUG

Topical minoxidil 5% daily for 180 days

Control Arm

Eligibility Criteria

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

You may qualify if:

• Clinically diagnosed with androgenetic alopecia (AGA)
• No pregnancy plans within the next 6 months

You may not qualify if:

• Patients who received systemic medications for hair loss within the past 2 months
• Use of topical medication for hair loss within the past 2 weeks
• Pregnancy or lactation
• 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

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

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)