An interventional study of Minoxidil 5 % and Microneedling in Androgenetic Alopecia, sponsored by Cheng Zhou. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Cheng Zhou · Not applicable, Interventional, and Treatment
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 190 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with Cheng Zhou as lead sponsor.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Minoxidil 5 % · Procedure: Microneedling
Drug: Minoxidil 5 % · Procedure: Microneedling
Drug: Minoxidil 5 % · Procedure: Microneedling
Drug: Minoxidil 5 % · Procedure: Microneedling
Procedure: Microneedling
Procedure: Microneedling
Drug: 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.
This trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks.
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
Time frame: 24 weeks
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Minoxidil