Clinical Efficacy and Mechanisms of Microneedling Alone or Combined With Drugs in the Treatment of Androgenetic Alopecia.
Study Design
- Loại nghiên cứu
- non-randomized controlled trial
- Cỡ mẫu
- 60
- Thời gian
- 16 weeks
- Can thiệp
- Clinical Efficacy and Mechanisms of Microneedling Alone or Combined With Drugs in the Treatment of Androgenetic Alopecia. Mild group: microneedling alone (8 weeks); Moderate group: microneedling + 5% minoxidil (12 weeks);
- Đối chứng
- Placebo
- Xu hướng hiệu quả
- Positive
- Nguy cơ sai lệch
- High
Abstract
OBJECTIVE: To investigate the clinical efficacy, safety, and underlying mechanisms of microneedling alone or combined with drugs for androgenetic alopecia (AGA), so as to provide evidence for the standardized clinical treatment. METHODS: A total of 60 male AGA patients admitted to our hospital from January 2023 to June 2025 were enrolled and stratified into mild, moderate, and severe groups (20 cases each) based on the Hair Loss Severity Score (HLSS). The mild group received microneedling alone, the moderate group received microneedling combined with minoxidil, and the severe group received microneedling combined with a mixed solution of minoxidil and finasteride. All patients were treated with a pen-type electric microneedle at a needling depth of 1 ± 0.5 mm (tolerated by patients), once weekly. The treatment course was 8 weeks for the mild group, 12 weeks for the moderate group, and 16 weeks for the severe group. Efficacy was evaluated using HLSS, hair density detection, and patient satisfaction (Visual Analog Scale, VAS) before and after treatment, with adverse reactions recorded. RESULTS: Before treatment, significant differences in HLSS and hair density were observed among the three groups (all p < 0.001), showing a gradient distribution of mild group < moderate group < severe group (for HLSS) and mild group > moderate group > severe group (for hair density). After treatment, HLSS significantly decreased (all p < 0.001) and hair density significantly increased (all p < 0.001) in all groups. Intergroup comparisons revealed that HLSS was mild group < moderate group < severe group, while hair density was mild group > moderate group > severe group (all p < 0.001). The moderate group had the highest patient satisfaction (8.5 ± 0.8 points), with significant differences among the three groups (p = 0.004). No severe adverse reactions occurred in all 60 patients; only 3 cases (5.0%) developed mild scalp erythema and swelling, which resolved spontaneously within 24-48 h. CONCLUSION: Microneedling exerts therapeutic effects by regulating hair growth signaling pathways and promoting transdermal drug delivery. It is effective for mild AGA when used alone, and achieves more significant efficacy in moderate to severe AGA when combined with drugs, with high safety. Thus, it is worthy of clinical promotion. However, this study has limitations such as a small sample size and male-only participants, and further multi-center, large-sample RCTs are needed for validation.
Full Text
Figures
Tables
TABLE 1
| Group | Number of cases | Before treatment | After treatment |
| Intragroup |
|---|---|---|---|---|---|
| Mild | 20 | 3.6 ± 0.5 | 2.1 ± 0.4# | 13.267 | < 0.001 |
| Moderate | 20 | 5.8 ± 0.6 | 3.2 ± 0.5# | 18.932 | < 0.001 |
| Severe | 20 | 7.5 ± 0.7 | 4.3 ± 0.6 | 21.548 | < 0.001 |
|
| — | 286.419 | 128.735 | — | — |
| Intergroup | — | < 0.001 | < 0.001 | — | — |
TABLE 2
| Group | Number of cases | Before treatment | After treatment |
| Intragroup |
|---|---|---|---|---|---|
| Mild | 20 | 86.4 ± 12.5 | 118.6 ± 15.3# | 8.724 | < 0.001 |
| Moderate | 20 | 62.3 ± 10.8 | 105.7 ± 13.6# | 12.351 | < 0.001 |
| Severe | 20 | 38.5 ± 9.6 | 82.4 ± 11.2 | 15.679 | < 0.001 |
|
| — | 136.825 | 68.937 | — | — |
| Intergroup | — | < 0.001 | < 0.001 | — | — |
References
- Expert Consensus on Clinical Application of Microneedling in Hair Regeneration (2025 Edition) Chinese Journal of Medical Aesthetics and Cosmetology, 2025
- Micro Needling: A Review of the Literature, A Novel Treatment Strategy for Androgenetic Alopecia Journal of Clinical and Diagnostic Research, 2025
- Therapeutic Efficacy of Platelet‐Rich Plasma Combining With Microneedling and Topical Minoxidil in Refractory Severe Androgenic Alopecia Journal of the American Academy of Dermatology, 2024
- Microneedling Induces Hair Growth by Activating Wnt/β‐Catenin Signaling Pathway in Androgenetic Alopecia Experimental Dermatology, 2023
- Efficacy of Microneedling Combined With Minoxidil in Male Androgenetic Alopecia: A Systematic Review and Meta‐Analysis Journal of Cosmetic Dermatology, 2024
- Microneedling in Female Androgenetic Alopecia: A Randomized Controlled Trial International Journal of Dermatology, 2024
- Multicenter Evaluation of Microneedling Combined With Minoxidil for Androgenetic Alopecia: A 12‐Month Follow‐Up Study British Journal of Dermatology, 2025
- Mechanisms of Microneedling in Hair Restoration: A Systematic Review of Preclinical and Clinical Studies Journal of Drug Delivery Science and Technology, 2024
- Enhanced Transdermal Delivery of Minoxidil via Microneedling: In Vitro and In Vivo Evaluation International Journal of Pharmaceutics, 2023
- Microneedling Promotes Hair Growth by Regulating Hair Follicle Stem Cell Proliferation and Differentiation Stem Cell Research & Therapy, 2024
- Androgenetic Alopecia: An Update on Pathogenesis and Management Journal of the American Academy of Dermatology, 2023
- Efficacy of Microneedling Alone Versus Microneedling With Minoxidil in Mild to Moderate Androgenetic Alopecia Journal of Cosmetic Laser Therapy, 2024
- Clinical Practice Guidelines for the Management of Androgenetic Alopecia (2024) Hair Transplant Surgery, 2024
- Safety Profile of Microneedling for Androgenetic Alopecia: A Meta‐Analysis of 23 Randomized Controlled Trials Dermatologic Surgery, 2025
- Female Pattern Hair Loss: Epidemiology, Pathogenesis, and Treatment Dermatologic Clinics, 2024
- Untitled Cochrane Handbook for Systematic Reviews of Interventions (Version 6.4), 2023
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