Currently submitted to: JMIR Dermatology
Date Submitted: Jul 19, 2026
Open Peer Review Period: Aug 3, 2026 - Sep 28, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety of Follicular Unit Transplant System FT-001 for Androgenetic Alopecia: A Prospective, Multicenter, Self-Controlled, Non-Inferiority Clinical Trial
ABSTRACT
Background:
Follicular unit excision (FUE) is the mainstream hair restoration approach for androgenetic alopecia (AGA), yet manual harvesting relies heavily on surgeon experience with unstable follicle integrity.
Objective:
To assess the efficacy and safety of FT-001 automated FUE system versus manual FUE in male AGA patients.
Methods:
This prospective, multicenter, self-controlled non-inferiority trial enrolled subjects at three Chinese tertiary hospitals. Each patient’s donor scalp was split into two randomized sides for FT-001 automated FUE (test) and surgeon-performed manual FUE (control). The primary outcome was hair transection rate; secondary outcomes covered follicular discard rate, recipient hair density and safety profiles. Efficacy was analyzed via full analysis set (FAS) and per-protocol set (PPS).
Results:
Fifty-five participants were recruited, and 51 males entered final analysis after excluding 4 females. FAS results showed mean transection rates of 7.79% (FT-001) and 7.09% (manual FUE; difference 0.70%, 95%CI −1.04%–2.44%, P<0.001). FT-001 yielded marginally higher follicular discard rate (2.35% vs 1.62%, P=0.021). Identical 11.76% mild folliculitis rates were recorded in both groups, with no severe adverse events or device complications.
Conclusions:
FT-001 achieves non-inferior efficacy and equivalent safety compared with expert manual FUE for male AGA treatment. Clinical Trial: This study was filed with the Shanghai Municipal Medical Products Administration (Registration No: 20230198).
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