Androgenic AlopeciaNCT07580521
Microneedling for Androgenic Alopecia: a Clinical Study
A study testing Microneedling monotherapy without drugs in people with Androgenic Alopecia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
A total of 20-30 patients with mild to moderate androgenic alopecia are expected to be enrolled. Inclusion criteria are patients aged ≥22 years; for males, Norwood's grading II-IV, and for females, Ludwig stage I-II. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Microneedling monotherapy without drugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥22 years
- Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)
Who cannot join
- Presence of obvious scalp wounds or other dermatologic lesions, including papulopustular rosacea, stage III-IV acne, eczema, herpes simplex, warts, scleroderma, bacterial or fungal infections, open wounds, actinic keratosis, or skin cancer
- Alopecia other than androgenetic alopecia
- Unilateral or uneven hair loss
- History of keloid formation or keloid tendency
- Pregnant women
- Patients with HIV infection
Show all 11Show fewer
- Coagulation abnormalities (international normalized ratio [INR] > 1.2, activated partial thromboplastin time [aPTT] > 40 seconds), thrombocytopenia (< 100,000/μL), hemophilia, or current use of antiplatelet or anticoagulant medications
- Patients with hepatitis B, hepatitis C, acquired immunodeficiency, or cancer
- Patients using a cardiac pacemaker or other similar implantable medical devices
- Patients using extracorporeal membrane oxygenation (ECMO) or other types of life-support equipment
- Patients using medical devices with electrocardiographic monitoring functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneedling for Androgenic Alopecia: A Clinical Study
A total of 20-30 patients with mild to moderate androgenic alopecia are expected to be enrolled. Inclusion criteria are patients aged ≥22 years; for males, Norwood's grading II-IV, and for females, Ludwig stage I-II. After enrollment, one researcher will use computer-generated randomization to assign each side of the patient's scalp to either the experimental group or the control group. The scalp side allocated to the experimental group will receive microneedling treatment once every two weeks (at baseline, and at weeks 2, 4, 6, 8, and 10; six sessions in total). The control side of the scalp will not receive microneedling or any topical treatment.
Treatment efficacy will be evaluated at baseline and at weeks 4, 8, 12, and 24 after trial initiation. Evaluation methods include trichoscopy and standardized photography. Photographs will be reviewed by assessing physicians to determine follicular density, hair density, hair thickness, the ratio of vellus to terminal hairs, and physician global assessment. The evaluating physicians will be blinded to which side is the experimental group and which side is the control group.
At Weeks 12 and 24 after the initiation of the study, the evaluating physician will perform the Physician Global Assessment (PGA) scale based on the captured photographs. In addition, patient satisfaction with the treatment will be assessed through physician-administered interviews using the Patient Global Assessment scale.
- Conditions
- Androgenic Alopecia
- Being tested
- Microneedling monotherapy without drugs
- Keywords
- androgenic alopecia, microneedling
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling monotherapy without drugsDevice
We use microneedling without application of drugs to participants.
| Study group | Role | What they receive |
|---|---|---|
| Microneeding to half of the scalp every two weeks with a total of 6 treatments. | Experimental | Not described Receives: Device: Microneedling monotherapy without drugs |
| No treatment to half of the scalp during the trial. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular density
The number of hair follicles per cm²
Measured: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
Hair density
The number of hair shafts per cm²
Measured: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
Hair thickness
Average hair thickness (µm) in 1 cm²
Measured: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
Vellus-to-terminal hair ratio
The total number of vellus hairs divided by the total number of terminal hairs in 1 cm²
Measured: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
Secondary outcomes (2)
Physician Global Assessment scale
On a scale of 0 to 6, 0: total clearance [100% improvement]
- almost total clearance [90% improvement]
- distinct clearance [75% improvement]
- moderate clearance [50% improvement]
- mild clearance [25% improvement]
- no change
- worse.
Measured: At Weeks 12 and 24 after the initiation of the trial.
Patient Global Assessment scale
On a scale of 0 to 10, 0: no improved, 5: moderately improved 10: fully improved.
Measured: At Weeks 12 and 24 after the initiation of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580521
- Sponsor's protocol ID
- N202509087
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling for Androgenic Alopecia: A Clinical Study
- ClinicalTrials.gov ID
- NCT07580521
- Acronym / sponsor ID
- N202509087
- Conditions
- Androgenic Alopecia
- Keywords
- androgenic alopecia, microneedling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 2026 (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.
A total of 20-30 patients with mild to moderate androgenic alopecia are expected to be enrolled. Inclusion criteria are patients aged ≥22 years; for males, Norwood's grading II-IV, and for females, Ludwig stage I-II. After enrollment, one researcher will use computer-generated randomization to assign each side of the patient's scalp to either the experimental group or the control group. The scalp side allocated to the experimental group will receive microneedling treatment once every two weeks (at baseline, and at weeks 2, 4, 6, 8, and 10; six sessions in total). The control side of the scalp will not receive microneedling or any topical treatment.
Treatment efficacy will be evaluated at baseline and at weeks 4, 8, 12, and 24 after trial initiation. Evaluation methods include trichoscopy and standardized photography. Photographs will be reviewed by assessing physicians to determine follicular density, hair density, hair thickness, the ratio of vellus to terminal hairs, and physician global assessment. The evaluating physicians will be blinded to which side is the experimental group and which side is the control group.
At Weeks 12 and 24 after the initiation of the study, the evaluating physician will perform the Physician Global Assessment (PGA) scale based on the captured photographs. In addition, patient satisfaction with the treatment will be assessed through physician-administered interviews using the Patient Global Assessment scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneeding to half of the scalp every two weeks with a total of 6 treatments. | Experimental | Device: Microneedling monotherapy without drugs |
| No treatment to half of the scalp during the trial. | No intervention | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥22 years
- Mild to moderate androgenic alopecia (for males, Norwood's grading II-IV, and for females, Ludwig stage I-II.)
Key exclusion criteria (11 listed)
- Presence of obvious scalp wounds or other dermatologic lesions, including papulopustular rosacea, stage III-IV acne, eczema, herpes simplex, warts, scleroderma, bacterial or fungal infections, open wounds, actinic keratosis, or skin cancer
- Alopecia other than androgenetic alopecia
- Unilateral or uneven hair loss
- History of keloid formation or keloid tendency
- Pregnant women
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 |
|---|---|---|
| Microneedling monotherapy without drugsWe use microneedling without application of drugs to participants. | Device | Microneeding to half of the scalp every two weeks with a total of 6 treatments. |
Primary outcome
Follicular density
Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
The number of hair follicles per cm²
Hair density
Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
The number of hair shafts per cm²
Hair thickness
Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
Average hair thickness (µm) in 1 cm²
Vellus-to-terminal hair ratio
Time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.
The total number of vellus hairs divided by the total number of terminal hairs in 1 cm²
2 secondary outcomes
Physician Global Assessment scale
Time frame: At Weeks 12 and 24 after the initiation of the trial.
Patient Global Assessment scale
Time frame: At Weeks 12 and 24 after the initiation of the trial.
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 21 Aug 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling monotherapy without drugs in people with Androgenic Alopecia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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 Taiwan. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular density (time frame: At baseline and at weeks 4, 8, 12, and 24 after trial initiation.). The study lists 4 primary outcomes in all. 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 21 Aug 2026.