UnknownNot Applicable

Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment

132 participantsStarted 2024-03

Plain-language summary

The goal of this clinical trial is to evaluate the effectiveness of FORTE, ACTIVE COVER LIGHT and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient having given freely her/his informed, written consent.
✓. Patient having a good general health.
✓. Age: more than 18 years.
✓. 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).
✓. Patient with positive KOH staining.
✓. 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.
✓. Patient being psychologically able to understand information and to give their/his/her consent.
✓. Patient having stopped any systemic antifungal treatment since at least 6 months before screening.

Exclusion criteria

✕. Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
✕. Patient considered by the investigator likely to be non-compliant with the protocol.
✕. Patient enrolled in another clinical trial or which exclusion period is not over.
✕. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
✕. 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…
✕. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
✕. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

What they're measuring

Percentage of healthy surface (Performance)

Timeframe: 270 days

Trial details

NCT IDNCT06254027

SponsorOystershell NV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06

View on ClinicalTrials.gov More Onychomycosis trials