CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS

Oystershell

Status: Enrolling

Conditions: Onychomycosis

Treatments: Device: Enriched; Drug: Loceryl 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06689852

23E1728

Details and patient eligibility

About

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

Full 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).

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 <2/3 of the tablets).

  2. 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.

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

  4. 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.

  5. 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.

  6. 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...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Enriched

Experimental group

Description:

To be used twice daily during 9 month

Treatment:

Device: Enriched

Loceryl

Experimental group

Description:

To be used 1 per week during 9 months

Treatment:

Drug: Loceryl 5%