Acne VulgarisEarly Phase 1NCT07007078
Efficacy of Dihydroartemisinin for Treating Acne Vulgaris
A Early Phase 1 study testing dihydroartemisinin in people with Acne Vulgaris, 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 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- dihydroartemisinin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed with acne vulgaris;
- For female patients, no pregnancy plans within the next 6 months.
Who cannot join
- 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 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 GAO, 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 Acne Vulgaris
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
- Being tested
- dihydroartemisinin
- Keywords
- acne vulgaris, dihydroartemisinin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisininDrug
DHA 40mg tid for 90 days
| Study group | Role | What they receive |
|---|---|---|
| DHA (dihydroartemisinin) Arm | Experimental | Not described Receives: Drug: dihydroartemisinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
An improvement of ≥30% in the GAGS score will be considered significant
Measured: Before and immediately after 90-day treatment
Change of inflammatory lesion count from baseline to the end of treatment
Measured: Before and immediately after 90-day treatment
Change of non-inflammatory lesion count from baseline to the end of treatment
Measured: Before and immediately after 90-day treatment
Number of participants who achieved an IGA score of 0 or 1 at the end of treatment
Measured: Before and immediately after 90-day treatment
Change of serum total testosterone from baseline to the end of treatment
Measured: Before and immediately after 90-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 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 Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07007078
- Sponsor's protocol ID
- B2025-113R
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 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 5 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 Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07007078
- Acronym / sponsor ID
- B2025-113R
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, dihydroartemisinin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 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
- 5 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHA (dihydroartemisinin) Arm | Experimental | Drug: dihydroartemisinin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically diagnosed with acne vulgaris;
- For female patients, no pregnancy plans within the next 6 months.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| dihydroartemisininDHA 40mg tid for 90 days | Drug | DHA (dihydroartemisinin) Arm |
Primary outcome
Improvement of acne severity by Investigator's Global Assessment (IGA)
Time frame: 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
5 secondary outcomes
Change of Global Acne Grading System (GAGS) score from baseline to the end of treatment
Time frame: Before and immediately after 90-day treatment
Change of inflammatory lesion count from baseline to the end of treatment
Time frame: Before and immediately after 90-day treatment
Change of non-inflammatory lesion count from baseline to the end of treatment
Time frame: Before and immediately after 90-day treatment
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
Change of serum total testosterone from baseline to the end of treatment
Time frame: Before and immediately after 90-day 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 5 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 dihydroartemisinin in people with Acne Vulgaris, 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 5 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 of acne severity by Investigator's Global Assessment (IGA) (time frame: Before and immediately after 90-day 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 5 Jun 2025.