NCT06254027

Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment

Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.

Detailed description

The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline. The secondary objectives are to evaluate: * Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture) * Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening) * Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire. * Their effectiveness, tolerance and acceptability based on patient's opinion. * Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Forte	One application per day for a complete treatment period.
DEVICE	Active Cover Light	One application per day for a complete treatment period.
DRUG	Loceryl	One application per week for a complete treatment period.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2024-02-12
• Last updated: 2024-02-12