Androgenetic Alopecia (AGA)Early Phase 1NCT07012486
Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia
A Early Phase 1 study testing Oral DHA + Topical minoxidil 5% and Topical Minoxidil 5% in people with Androgenetic Alopecia (AGA), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- Oral DHA + Topical minoxidil 5% and Topical Minoxidil 5%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed with androgenetic alopecia (AGA)
- No pregnancy plans within the next 6 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Lujuan, MD, PhD, 86-021-64041990, gao.lujuan@zs-hospital.sh.cn
About this study
Official title: A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Female Androgenetic Alopecia
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)
- Being tested
- Oral DHA + Topical minoxidil 5%, Topical Minoxidil 5%
- Keywords
- androgenetic alopecia, dihydroartemisinin
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral DHA + Topical minoxidil 5%Drug
DHA 20mg tid po plus daily topical minoxidil 5% for 180 days
Topical Minoxidil 5%Drug
Topical minoxidil 5% daily for 180 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | oral dihydroartemisinin (DHA) combined with topical minoxidil Receives: Drug: Oral DHA + Topical minoxidil 5% |
| Control Arm | Other | topical minoxidil alone Receives: Drug: Topical Minoxidil 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 180-day of treatment
Change of hair density in the vertex area from baseline to the end of treatment
Measured: Baseline and 180-day of treatment
Change of terminal hair follicle density in the frontal area from baseline to the end of treatment
Terminal hair follicle density in the frontal area
Measured: Baseline and 180-day of treatment
Change of hair density in the frontal area from baseline to the end of treatment
Measured: Baseline and 180-day of treatment
Change of serum total testosterone from baseline to the end of treatment
Measured: Baseline and 180-day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingjing JIANG, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012486
- Sponsor's protocol ID
- B2025-112R
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Female Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07012486
- Acronym / sponsor ID
- B2025-112R
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- androgenetic alopecia, dihydroartemisinin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Drug: Oral DHA + Topical minoxidil 5%oral dihydroartemisinin (DHA) combined with topical minoxidil |
| Control Arm | Other | Drug: Topical Minoxidil 5%topical minoxidil alone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically diagnosed with androgenetic alopecia (AGA)
- No pregnancy plans within the next 6 months
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral DHA + Topical minoxidil 5%DHA 20mg tid po plus daily topical minoxidil 5% for 180 days | Drug | Intervention Arm |
| Topical Minoxidil 5%Topical minoxidil 5% daily for 180 days | Drug | Control Arm |
Primary outcome
Improvement in terminal hair follicles in the vertex area
Time frame: Baseline and 180-day of treatment
Terminal hair follicles in the vertex area will be quantified before and at the end of treatment
5 secondary outcomes
Change of terminal hair follicle density in the vertex area from baseline to the end of treatment
Time frame: Baseline and 180-day of treatment
Change of hair density in the vertex area from baseline to the end of treatment
Time frame: Baseline and 180-day of treatment
Change of terminal hair follicle density in the frontal area from baseline to the end of treatment
Time frame: Baseline and 180-day of treatment
Change of hair density in the frontal area from baseline to the end of treatment
Time frame: Baseline and 180-day of treatment
Change of serum total testosterone from baseline to the end of treatment
Time frame: Baseline and 180-day of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingjing JIANG, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral DHA + Topical minoxidil 5% and Topical Minoxidil 5% in people with Androgenetic Alopecia (AGA), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lujuan GAO, MD, PhD (86-021-64041990, gao.lujuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in terminal hair follicles in the vertex area (time frame: Baseline and 180-day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.