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NCT Number: NCT07758400

A Study on the Efficacy and Safety of Microneedling for Male Androgenetic Alopecia

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location contact

Cheng Zhou, Chief physician

CONTACT

[email protected]

010 88325470

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

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.

Microneedling

Procedure

This trial adopts standardized microneedling parameters with defined needle depths and treatment frequencies combined with fixed-dose 5% topical minoxidil for 24 consecutive weeks.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Zhou, Chief physician

CONTACT

[email protected]

010 88325470

Sponsors and collaborators

Lead sponsor

Cheng Zhou

Other

Registry information

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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