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First received: October 02, 2023

Clinical Trial: Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Study Status: Completed

Recruit Status: RECRUITING

Condition: Distal Lateral Subungual Onychomycosis

Study Type: INTERVENTIONAL


Official Title: Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Brief Summary: This is a Pre-IDE, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of Nail Genesis DLSO Product for the treatment of DLSO compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females between 18 and 65 years of age (inclusive).Subjects will be randomized in a 2:1 ratio to receive either Nail Genesis DLSO Product or vehicle.Subject eligibility will be determined during a Screening…

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