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.
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%
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
One application per day for a complete treatment period.
One application per day for a complete treatment period.
One application per week for a complete treatment period.
Percentage of healthy surface (Performance)
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical devices (FORTE or ACTIVE COVER LIGHT) or reference product (Loceryl) versus baseline value.
Time frame: 270 days
Percentage of healthy surface (Performance)
Variation of the percentage of healthy nail surface versus baseline value.
Time frame: 30 days; 90 days; 180 days
Microbiological efficacy: KOH staining (Performance)
Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.
Time frame: 270 days (month 9)
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Evaluation of the visual appearance of the nail by assessing following parameters: onycholysis, nail dystrophy, nail discoloration, and nail thickening by the investigator in live. Each parameter is scored from 0 (none) - 4 (severe). The total score of all parameters is an indication of the visual appearance of the nail.
Time frame: Baseline, 30 days; 90 days, 180 days; 270 days
Clinical efficacy: onychomycosis evolution (Performance)
Assessment of onychomycosis evolution by the investigator in live by scoring: 1. \- Failure: increase in the total infected area or aggravation 2. \- Status Quo 3. \- Improvement: decrease of the total infected area 4. \- Success: Disappearance of the total infected area
Time frame: 30 days; 90 days; 180 days; 270 days
Impact on quality of life (Performance)
Evaluation of the impact on the quality of life (QoL) of patients using a validated questionnaire (NailQoL). The questionnaire contains 15 questions, each using the scoring: * 0 (never) * 25 (rarely) * 50 (sometimes) * 75 (often) * 100 (all the time)
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Time frame: Baseline, 30 days; 90 days, 180 days; 270 days
Subjective evaluation questionnaire for the patient (Performance)
Evaluation of efficacy, tolerance, and acceptability of the test medical devices and reference by the patients using a subjective evaluation questionnaire. The subjective evaluation questionnaire uses a scoring (Completely Agree, Agree, Neutral, Disagree or Completely disagree) or uses 'Yes/No'- questions to be able to provide a score for performance. Some open questions are added to allow the patients to elaborate on certain answers in order to have a better understanding of their response.
Time frame: 14 days; 30 days; 90 days; 180 days; 270 days
Evaluation of tolerance
Evaluation of tolerance of the test medical devices and reference. Assessment is performed by the investigator via clinical evaluation and subject interrogation. The investigator will assign a score between 0 (bad tolerance) to 3 (very good tolerance).
Time frame: 30 days; 90 days; 180 days; 270 days