Clinical trial NCT03289871: Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Official title: Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2017-09-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject having given her/his informed, written consent,
* Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
* Subject being psychologically able to understand information and to give their/his/her consent.
* Age: more than 18 years.
* Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
* Subject with positive results of KOH staining.
* Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
* Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.

Exclusion Criteria:

* Subject considered by the Investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.
* Woman being pregnant, nursing or planning a pregnancy during the course of this study.
* Subject having a known allergy to one of the constituents of the tested products.
* Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology....
* Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).

Primary outcomes:
measure: 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.
timeFrame: After 168 days of treatment
Secondary outcomes:
measure: At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
timeFrame: After 14, 28, 56 and 112 days of treatment
measure: Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
timeFrame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
measure: Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
timeFrame: On baseline (day zero) and day 168
measure: 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).
timeFrame: After 14, 28, 56 and 112 days of treatment
measure: Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
timeFrame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
measure: Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
timeFrame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Hospital Habib Thameur
city: Tunis
country: Tunisia
facility: Principal instruction military hospital
Study officials:
affiliation: Principal Instruction military hospital of Tunis
name: Nejib Doss, MD
role: PRINCIPAL_INVESTIGATOR
References: