Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06254027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment
Sponsor:
Oystershell NV
Organization:
Study Overview
Official Title:
Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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%
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%
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: