An interventional study of Excilor and Loceryl 5% in Onychomycosis, sponsored by Oystershell NV. Completed at 2 sites in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-21.
Sponsored by Oystershell NV · Not applicable, Interventional, and Treatment
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.
Exclusion Criteria:
2 applications per day for 6 months
Device: Excilor
1 application per week for 6 months
Drug: Loceryl 5%
At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time frame: After 168 days of treatment
At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time frame: After 14, 28, 56 and 112 days of treatment
Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
Time frame: On baseline (day zero) and day 168
Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).
Time frame: After 14, 28, 56 and 112 days of treatment
Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
Time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Oystershell NV