NCT06074315

Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: Nail Genesis LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 assessment. Subjects will complete a 4week washout period after discontinuation of a topical product or a 12-month washout period after discontinuation of an oral product or light-based therapy prior to randomization. Eligible subjects will be randomized in a 2:1 ratio to receive Nail Genesis DLSO Product or vehicle, respectively. During the 52-week trial, study medication will be administered once daily to the target toenail for 48 weeks. A subject will be considered to have completed the study when he or she has completed the study assessments at Week 52. The 52-week visit is for follow-up safety assessments.

Conditions

• Distal Lateral Subungual Onychomycosis
• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Nail Genesis DLSO Product	Nail fungus is difficult to treat with topical drugs because of the thickness of the nails (Murdan, 2002). Nail Genesis DLSO Product does not contain a drug or antifungal agent and so is not designed to have a direct action on the microorganism, but instead will act by changing the conditions that allow growth of the fungus (i.e., keeping the nail plate and underlying nail bed dry and inhibiting secondary infection).
DEVICE	Nail Genesis DLSO Product (vehicle only)	The Nail Genesis DLSO product poly-urethane vehicle

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-10-10
• Last updated: 2023-12-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study