NCT07758400

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

  • 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

    24 weeks

Study Arms (7)

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 %

Interventions

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.

5% topical minoxidil aloneMicroneedling 0.5 mm every 1 week plus 5% topical minoxidilMicroneedling 0.5 mm every 2 weeks plus 5% topical minoxidilMicroneedling 1mm every 1 week plus 5% topical minoxidilMicroneedling 1mm every 2 weeks plus 5% topical minoxidil
MicroneedlingPROCEDURE

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 0.5 mm every 1 week plus 5% topical minoxidilMicroneedling 0.5 mm every 2 weeksMicroneedling 0.5 mm every 2 weeks plus 5% topical minoxidilMicroneedling 1 mm every 2 weeksMicroneedling 1mm every 1 week plus 5% topical minoxidilMicroneedling 1mm every 2 weeks plus 5% topical minoxidil

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Alopecia

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Central Study Contacts

Cheng Zhou, Chief physician

CONTACT

010 88325470rmpkzc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations

CN(1)