The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
1. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablets).
None
Parallel
Enriched
DeviceTo be used twice a day
Loceryl 5%
DrugTo be used once a week
Blinded evaluation of the percentage of healthy nail surface
Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
Percentage of healthy surface (performance)
Variation of the percentage of healthy surface after 90 days (3 months) and 180 days (6 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.
Mirobiological efficacy ; KOH staining (Performance)
Evaluation of microbiological efficacy of both treatments versus baseline by KOH staining and fungal culture at D270 (month 9)
Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
Assessment of clinical efficacy of both treatments on D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9) by evaluation of the 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.
Clinical efficacy: onychomycosis evolution (Performance)
Assessment of onychomycosis evolution on D90 (month 3), D180 (month 6) and D270 (month 9) by the investigator in live * Failure: increase in the total infected area or aggravation * Status Quo * Improvement: decrease of the total infected area * Success: Disappearance of the total infected area
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Oystershell NV
Lead sponsor
Eurofins Dermscan Pharmascan
Collaborator
