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
Male patients aged 18 to 40 years.
Clinical diagnosis of androgenetic alopecia confirmed by history, scalp examination, and dermoscopy.
Norwood-Hamilton grade II or III androgenetic alopecia.
Presence of visible hair follicles in the target scalp area on dermoscopy.
Significant systemic illness affecting safety, wound healing, or hair growth (e.g., neuromuscular disorders, uncontrolled diabetes, autoimmune disease, hematological disease, active malignancy, or recent chemotherapy).
Active scalp infection, inflammation, dermatitis, wounds, scarring, or other skin lesions at the treatment area.
Other causes of alopecia (alopecia areata, telogen effluvium, traction alopecia, cicatricial alopecia, thyroid-related hair loss, iron deficiency-related hair loss, or drug-induced alopecia).
Any previous topical treatment for AGA within the past 1-2 months.
Parallel
Botulinum Toxin Type A
DrugA 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
Procedure/SurgeryA 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).
Change in Total Hair Count
Measurement of the change in total hair count per target area on the scalp from baseline to 6 months post-treatment using dermoscopic assessment
Change in Terminal Hair Count
Change in Vellus Hair Count
Change in Terminal to Vellus Ratio
Change in Follicular Unit Pattern
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Sherief Ayman Hussein Shaamash
Lead sponsor
Assiut University
Sponsor institution
Assiut University
Collaborator
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