Androgenetic AlopeciaNCT07758400
A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia
A study testing Minoxidil 5 % and Microneedling in people with Androgenetic Alopecia, run by Cheng Zhou at 1 site in China.
Trial summary
Androgenetic alopecia (AGA) is the most prevalent hair-loss disorder in clinical practice. With a high incidence rate, it not only severely impairs patients' appearance and quality of life, but may also trigger varying degrees of depression and compromise mental health, highlighting the critical importance of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil 5 % and Microneedling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Jun 2030
- 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 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects aged 18-55 years.
- Diagnosed with androgenetic alopecia (AGA)
- Hamilton-Norwood hair-loss grade: Ⅲ vertex, Ⅳ, Ⅴ, or Ⅵ.
- Willing to receive scalp photography for assessment, and maintain consistent hairstyle, hair color and hair length at each follow-up visit.
- Understand the trial objectives, voluntarily provide written informed consent, and be willing and able to comply with the study protocol including scheduled follow-up visits and outcome evaluations.
Who cannot join
- Presence of other hair-loss disorders, including telogen effluvium, alopecia areata, lichen planopilaris, discoid lupus erythematosus, tinea capitis, and chemotherapy- or radiotherapy-induced alopecia.
- Subjects with prior anti-hair-loss treatments: oral finasteride or dutasteride within 1 year before screening; other oral or topical hair-growth-promoting agents (e.g., minoxidil) within 6 months before screening; physical therapies for hair loss within 6 months before screening, including low-level laser therapy, microneedling, fractional laser, injection of PRP/PRF/CGF, scalp botulinum toxin injection; hair-growth-promoting cosmetic hair-care products, nutritional supplements, medicinal shampoos, serums or solutions that may interfere with efficacy evaluation within 1 month before screening; prior hair-transplantation surgery or hair-extension history.
- Major surgery within 3 months planned major surgery during the trial period.
- Participation in other drug or medical-device clinical trials within 3 months prior to screening.
- Hair perming and/or hair dyeing within 3 months prior to screening.
- Uncontrolled chronic or systemic diseases (e.g., hypertension, diabetes, bleeding disorders, severe infection, immune-system diseases, malignancy, hepatitis, thyroid disorders).
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- Co-existing diseases affecting hair growth, such as connective-tissue diseases, inflammatory bowel disease, moderate-to-severe anemia, significant weight loss (>5 kg within 3 months).
- Keloid predisposition: history of keloid/hypertrophic scars or clinically confirmed hypertrophic scars/keloids at any body site.
- Known allergy to any components of microneedling devices or minoxidil.
- Psychiatric disorders or emotional instability.
- Any other conditions that, in the investigator's opinion, make the subject unsuitable for trial participation.
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
Peking University People's Hospital
Beijing, Beijing Municipality
Cheng Zhou, Chief physician, 010 88325470, rmpkzc@163.com
About this study
Androgenetic alopecia (AGA) is the most prevalent hair-loss disorder in clinical practice. With a high incidence rate, it not only severely impairs patients' appearance and quality of life, but may also trigger varying degrees of depression and compromise mental health, highlighting the critical importance of standardized management for AGA. Current therapeutic options for AGA include oral finasteride, topical minoxidil, physical therapies and others. Nevertheless, safety concerns over oral medications remain prominent. Finasteride, a first-line agent, is associated with adverse reactions such as decreased libido, erectile dysfunction and reduced ejaculate volume, which limits patient acceptance. In recent years, microneedling for AGA has attracted attention, clinical adoption and recognition among dermatologists, demonstrating favorable safety profiles and promising therapeutic outcomes in real-world clinical practice. Minoxidil is an effective hair-growth-promoting drug. Topical 2% or 5% minoxidil exhibits satisfactory efficacy and safety for AGA and is frequently combined with other interventions to enhance treatment benefits.
Microneedling combined with topical minoxidil represents a commonly-used regimen for AGA in clinical settings. However, substantial heterogeneity exists regarding microneedling parameters including needle depth, treatment frequency and total treatment duration across medical institutions and clinical studies. Needle depth is closely correlated with patient perception, therapeutic efficacy and adverse events such as bleeding; treatment frequency is strongly linked to patient compliance and clinical outcomes. Despite the widespread clinical use of microneedling, standardized treatment protocols are still lacking, which greatly undermines the standardization, treatment efficacy and patient compliance of physical therapy for androgenetic alopecia.
This study plans to enroll 190 male patients with AGA. Participants will be stratified into different groups according to microneedling depth and treatment frequency, and receive standardized intervention for 24 weeks. The primary objective is to explore the optimal microneedling regimen (including needle depth and treatment frequency). We will also evaluate how disease course, hair-loss classification and severity grading influence therapeutic efficacy and safety among AGA patients. Findings from this trial will provide evidence-based references for dermatologists to deliver precise and individualized AGA care, support the development of clinical guidelines, and facilitate standardized clinical implementation of this combination therapy.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil 5 %, Microneedling
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil 5 %Drug
This trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks.
MicroneedlingProcedure or surgery
This trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling 0.5 mm every 2 weeks plus 5% topical minoxidil | Experimental | Not described Receives: Drug: Minoxidil 5 %; Procedure: Microneedling |
| Microneedling 0.5 mm every 1 week plus 5% topical minoxidil | Experimental | Not described Receives: Drug: Minoxidil 5 %; Procedure: Microneedling |
| Microneedling 1mm every 2 weeks plus 5% topical minoxidil | Experimental | Not described Receives: Drug: Minoxidil 5 %; Procedure: Microneedling |
| Microneedling 1mm every 1 week plus 5% topical minoxidil | Experimental | Not described Receives: Drug: Minoxidil 5 %; Procedure: Microneedling |
| Microneedling 0.5 mm every 2 weeks | Experimental | Not described Receives: Procedure: Microneedling |
| Microneedling 1 mm every 2 weeks | Experimental | Not described Receives: Procedure: Microneedling |
| 5% topical minoxidil alone | Active comparator | Not described Receives: Drug: Minoxidil 5 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target area non-vellus hair count
The change in the number of target area non-vellus hair count compared to the baseline at 24 weeks of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng Zhou, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758400
- Sponsor's protocol ID
- WZ-2026
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07758400
- Acronym / sponsor ID
- WZ-2026
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Cheng ZhouUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 11 Aug 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.
Androgenetic alopecia (AGA) is the most prevalent hair-loss disorder in clinical practice. With a high incidence rate, it not only severely impairs patients' appearance and quality of life, but may also trigger varying degrees of depression and compromise mental health, highlighting the critical importance of standardized management for AGA. Current therapeutic options for AGA include oral finasteride, topical minoxidil, physical therapies and others. Nevertheless, safety concerns over oral medications remain prominent. Finasteride, a first-line agent, is associated with adverse reactions such as decreased libido, erectile dysfunction and reduced ejaculate volume, which limits patient acceptance. In recent years, microneedling for AGA has attracted attention, clinical adoption and recognition among dermatologists, demonstrating favorable safety profiles and promising therapeutic outcomes in real-world clinical practice. Minoxidil is an effective hair-growth-promoting drug. Topical 2% or 5% minoxidil exhibits satisfactory efficacy and safety for AGA and is frequently combined with other interventions to enhance treatment benefits.
Microneedling combined with topical minoxidil represents a commonly-used regimen for AGA in clinical settings. However, substantial heterogeneity exists regarding microneedling parameters including needle depth, treatment frequency and total treatment duration across medical institutions and clinical studies. Needle depth is closely correlated with patient perception, therapeutic efficacy and adverse events such as bleeding; treatment frequency is strongly linked to patient compliance and clinical outcomes. Despite the widespread clinical use of microneedling, standardized treatment protocols are still lacking, which greatly undermines the standardization, treatment efficacy and patient compliance of physical therapy for androgenetic alopecia.
This study plans to enroll 190 male patients with AGA. Participants will be stratified into different groups according to microneedling depth and treatment frequency, and receive standardized intervention for 24 weeks. The primary objective is to explore the optimal microneedling regimen (including needle depth and treatment frequency). We will also evaluate how disease course, hair-loss classification and severity grading influence therapeutic efficacy and safety among AGA patients. Findings from this trial will provide evidence-based references for dermatologists to deliver precise and individualized AGA care, support the development of clinical guidelines, and facilitate standardized clinical implementation of this combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Microneedling 0.5 mm every 2 weeks plus 5% topical minoxidil | Experimental | Drug: Minoxidil 5 %, Procedure: Microneedling |
| Microneedling 0.5 mm every 1 week plus 5% topical minoxidil | Experimental | Drug: Minoxidil 5 %, Procedure: Microneedling |
| Microneedling 1mm every 2 weeks plus 5% topical minoxidil | Experimental | Drug: Minoxidil 5 %, Procedure: Microneedling |
| Microneedling 1mm every 1 week plus 5% topical minoxidil | Experimental | Drug: Minoxidil 5 %, Procedure: Microneedling |
| Microneedling 0.5 mm every 2 weeks | Experimental | Procedure: Microneedling |
| Microneedling 1 mm every 2 weeks | Experimental | Procedure: Microneedling |
| 5% topical minoxidil alone | Active comparator | Drug: Minoxidil 5 % |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged 18-55 years.
- Diagnosed with androgenetic alopecia (AGA)
- Hamilton-Norwood hair-loss grade: Ⅲ vertex, Ⅳ, Ⅴ, or Ⅵ.
- Willing to receive scalp photography for assessment, and maintain consistent hairstyle, hair color and hair length at each follow-up visit.
- Understand the trial objectives, voluntarily provide written informed consent, and be willing and able to comply with the study protocol including scheduled follow-up visits and outcome evaluations.
Key exclusion criteria (11 listed)
- Presence of other hair-loss disorders, including telogen effluvium, alopecia areata, lichen planopilaris, discoid lupus erythematosus, tinea capitis, and chemotherapy- or radiotherapy-induced alopecia.
- Subjects with prior anti-hair-loss treatments: oral finasteride or dutasteride within 1 year before screening; other oral or topical hair-growth-promoting agents (e.g., minoxidil) within 6 months before screening; physical therapies for hair loss within 6 months before screening, including low-level laser therapy, microneedling, fractional laser, injection of PRP/PRF/CGF, scalp botulinum toxin injection; hair-growth-promoting cosmetic hair-care products, nutritional supplements, medicinal shampoos, serums or solutions that may interfere with efficacy evaluation within 1 month before screening; prior hair-transplantation surgery or hair-extension history.
- Major surgery within 3 months planned major surgery during the trial period.
- Participation in other drug or medical-device clinical trials within 3 months prior to screening.
- Hair perming and/or hair dyeing within 3 months prior to screening.
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 |
|---|---|---|
| Minoxidil 5 %This trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks. | Drug | 5% topical minoxidil alone, Microneedling 0.5 mm every 1 week plus 5% topical minoxidil, Microneedling 0.5 mm every 2 weeks plus 5% topical minoxidil, Microneedling 1mm every 1 week plus 5% topical minoxidil, Microneedling 1mm every 2 weeks plus 5% topical minoxidil |
| MicroneedlingThis trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks. | Procedure or surgery | Microneedling 0.5 mm every 1 week plus 5% topical minoxidil, Microneedling 0.5 mm every 2 weeks, Microneedling 0.5 mm every 2 weeks plus 5% topical minoxidil, Microneedling 1 mm every 2 weeks, Microneedling 1mm every 1 week plus 5% topical minoxidil, Microneedling 1mm every 2 weeks plus 5% topical minoxidil |
Primary outcome
Target area non-vellus hair count
Time frame: 24 weeks
The change in the number of target area non-vellus hair count compared to the baseline at 24 weeks 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 11 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minoxidil 5 % and Microneedling in people with Androgenetic Alopecia, run by Cheng Zhou 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 5 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: opening soon, as of the sponsor's last update on 11 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 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.
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 Cheng Zhou, Chief physician (010 88325470, rmpkzc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target area non-vellus hair count (time frame: 24 weeks). 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 11 Aug 2026.