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| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forte | Experimental | Device: One application per day for 9 months. |
|
| Active Cover Light | Experimental | Device: One application per day for 9 months. |
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| Loceryl 5% | Active Comparator | Drug: Loceryl 5% One application per week for 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forte | Device | One application per day for a complete treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 270 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healthy surface (Performance) | Variation of the percentage of healthy nail surface versus baseline value. | 30 days; 90 days; 180 days |
| Microbiological efficacy: KOH staining (Performance) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C038974 | amorolfine |
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Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
| Active Cover Light | Device | One application per day for a complete treatment period. |
|
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| Loceryl | Drug | One application per week for a complete treatment period. |
|
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Evaluation of microbiological efficacy versus baseline by KOH staining and fungal culture.
| 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. | 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:
| 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:
| 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. | 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). | 30 days; 90 days; 180 days; 270 days |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |