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Botulinum Toxin A vs Nanofat for Male Androgenetic Alopecia
NCT07863856Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Conditions
- androgenetic alopecia (AGA)
01
Overview
Phase 3, randomised, single-blind trial of botulinum toxin type A in androgenetic alopecia (AGA) (2 arms). Primary endpoint: Change in Total Hair Count at 6 months. Planned start Dec 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Botulinum Toxin A
Single session of Botulinum Toxin Type A (100 U diluted in 2 mL normal saline) injected intramuscularly across 30 points.
Autologous Nanofat
Single session of autologous nanofat intradermal injection harvested from donor site and injected into balding scalp.
03
Who it enrols
Male patients aged 18-40 with Norwood-Hamilton grade II or III androgenetic alopecia, excluding those with significant systemic illnesses, active scalp infections, or recent use of hair-growth-altering medications.
04
Endpoints
Primary
Change in Total Hair Count
Secondary
Change in Terminal Hair Count
Change in Vellus Hair Count
Change in Terminal to Vellus Ratio
Change in Follicular Unit Pattern
Change in Hair Shaft Diameter Diversity
Change in Yellow Dots Sign
Change in Peripilar Sign
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