Clinical trial NCT06689852: CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS
Official title: MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Onychomycosis
Keywords: onychomycosis
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Dermscan Pharmascan
First posted: 2024-11-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

Detailed description: Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).

Eligibility criteria: Inclusion Criteria:

* 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 \&lt;2/3 of the tablets).

  5. Patient with positive KOH staining. 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.

  7. Patient being psychologically able to understand information and to give their/his/her consent.

  8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.

  9. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.

  10. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.

Exclusion Criteria:

- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology... 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.

7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).

Primary outcomes:
measure: Blinded evaluation of the percentage of healthy nail surface
timeFrame: 270 days
Secondary outcomes:
measure: Percentage of healthy surface (performance)
timeFrame: 90 days, 180 days
measure: Mirobiological efficacy ; KOH staining (Performance)
timeFrame: 270 days
measure: Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
timeFrame: 90 days, 180 days, 270 days
measure: Clinical efficacy: onychomycosis evolution (Performance)
timeFrame: 90 days, 180 days, 270 days
measure: Impact on quality of life (Performance)
timeFrame: 180 days, 270 days
measure: Subjective evaluation questionnaire for the patient (Performance)
timeFrame: 14 days, 90 days, 180 days, 270 days
measure: Evaluation of tolerance
timeFrame: 90 days, 180 days, 270 days
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Eurofins Dermscan Pharmascan
Study officials:
References: