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

Last updated: November 13, 2024
Sponsor: Oystershell NV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Toenail Fungus (Onychomycosis)

Treatment

Enriched

Loceryl 5%

Clinical Study ID

NCT06689852
23E1728
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient having given freely her/his informed, written consent. 2. Patienthaving a good general health. 3. Age: between 18 and 70 years; 4. Patient withsuperficial onychomycosis on at least one great toenail or fingernail (for atleast 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 theproducts modalities of use and the necessity and duration of the controls sothat perfect adhesion to the protocol can be expected.

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

  4. Patient having stopped any systemic antifungal treatment since at least 6months 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 nailsand/or cosmetic nail varnish or other medication on the nail being treated forthe entire study duration.

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

Exclusion

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 theprotocol. 3. Patient enrolled in another clinical trial or which exclusionperiod is not over. 4. Patient with a condition or receiving a medicationwhich, in the investigator's judgment, put the patient at undue risk; 5.Patient suffering from a severe or progressive disease (to investigator'sdiscretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV,psoriasis, lichen planus, immunosuppressive pathology... 6. Patient having aknown allergy or hypersensitivity to one of the constituents of the testedproducts.

  3. Patient with cutaneous pathology on studied zone (other than onychomycosis likeangioma, dermatitis...).

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Enriched
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
April 30, 2026

Study 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).

Connect with a study center

  • Eurofins Dermscan Pharmascan

    Villeurbanne, 69100
    France

    Active - Recruiting

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