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.