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Efficacy of Botulinum Toxin A Versus Nanofat in the Treatment of Androgenetic Alopecia: A Comparative Clinical Trial
Sponsor: Sherief Ayman Hussein Shaamash
Summary
The goal of this clinical trial is to learn whether botulinum toxin A (BTA) or autologous nanofat injection is more effective for treating male androgenetic alopecia. It will also assess the safety of both treatments. The main questions it aims to answer are: * Does botulinum toxin A or nanofat produce a greater increase in total hair count after 6 months? * How do the treatments affect terminal hairs, vellus hairs, hair shaft characteristics, and other dermoscopic features? * What side effects occur with each treatment? * How satisfied are participants with the improvement in their hair condition? Researchers will compare intramuscular botulinum toxin A injections with intradermal autologous nanofat injections in men aged 18 to 40 years with Norwood Hamilton grade II or III androgenetic alopecia. Participants will: * Be randomly assigned to receive either botulinum toxin A or nanofat * Receive one treatment session at the beginning of the study * Have clinical, dermoscopic, and photographic assessments at baseline, 3 months, and 6 months * Have changes in total hair count and other hair characteristics measured during follow-up * Report any treatment-related side effects and their satisfaction with the result
Key Details
Gender
MALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-12
Completion Date
2028-10
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Botulinum Toxin Type A
A single baseline treatment consisting of 100 U of Botulinum Toxin Type A diluted in 2.0 mL of 0.9% sterile normal saline. The solution is administered via intramuscular injection distributed across 30 evenly spaced injection sites (\~3.3 U per point, 2 cm apart, target depth 4 mm) into the scalp and surrounding musculature, specifically targeting the frontal hairline, temporalis, periauricular, and occipitalis muscles.
Autologous Nanofat Injection
A single baseline treatment of autologous nanofat intradermal injection into the balding scalp regions. Lipoaspirate is harvested from the donor site (lower abdomen, flank, or thigh) under local infiltration anesthesia, washed with sterile saline, mechanically emulsified by shifting between two luer-lock syringes connected with a transfer connector, and passed through a micro-filter. The resulting nanofat liquid is injected intradermally into affected scalp zones using a micro-bolus technique (\~0.1 mL per point, 1 cm apart).
Locations (1)
Assiut University Hospitals, Dermatology Department
Asyut, Asyut Governorate, Egypt