NCT07863856|Not Yet RecruitingPhase 2/3DMC
Efficacy of Botulinum Toxin A Versus Nanofat in the Treatment of Androgenetic Alopecia: A Comparative Clinical Trial
AGA
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Sponsor study identifier
interventional
40
1 country
1
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2026
Actual (reported)October 7, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Baseline to 6 months
Change in Terminal Hair Count
Baseline to 6 months
Change in Vellus Hair Count
Baseline to 6 months
Change in Terminal to Vellus Ratio
Baseline to 6 months
Change in Follicular Unit Pattern
Baseline to 6 months
Change in Hair Shaft Diameter Diversity
Baseline to 6 months
Participants will receive a single session of Botulinum Toxin Type A (100 U diluted in 2 mL normal saline). The solution is injected intramuscularly across 30 evenly spaced points (2 cm apart, depth 4 mm, \~3.3 U per point) into the frontal hairline, temporalis, periauricular, and occipitalis muscles.
Participants will receive a single session of autologous nanofat intradermal injection. Lipoaspirate is harvested from the lower abdomen, flank, or thigh under local anesthesia, washed, mechanically emulsified between syringes via Luer lock connectors, and filtered. It is then injected intradermally into the balding scalp using a micro-bolus technique (\~0.1 mL per point, 1 cm apart).
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.
Assiut University Hospitals, Dermatology Department
Asyut, Asyut Governorate, 71515, Egypt
Eman Riad Hofny, Prof. Dr.
Assiut University Faculty of Medicine
Yasmeen Mostafa Tawfik, Prof. Dr.
Assiut University Faculty of Medicine
First Submitted
September 28, 2026
First Posted
October 7, 2026
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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