Clinical trial NCT03382717: Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Official title: Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis of Toenail
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 102
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® Forte" 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.

Detailed description: Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.

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 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 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 uncontrolled 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: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
timeFrame: After 30, 60, 120 and 180 days of treatment
Secondary outcomes:
measure: Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
timeFrame: After 30, 60, 120 and 180 days of treatment
measure: Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
timeFrame: At baseline (day 0) and after 180 days of treatment
measure: Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
timeFrame: After 30, 60, 120 and 180 days of treatment
measure: Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
timeFrame: After 60 and 180 days of treatment
measure: Subject evaluation using an evaluation questionnaire, performed at each visit.
timeFrame: After 30, 60, 120 and 180 days of treatment
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:
citation: Eertmans F, Doss N, Rossel B, Adriaens E. Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial. Dermatol Ther (Heidelb). 2018 Sep;8(3):463-473. doi: 10.1007/s13555-018-0254-1. Epub 2018 Jul 26.