Clinical trial NCT06254027: Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for Onychomycosis Treatment
Official title: Multicentric, Randomized, Evaluator Blinded Clinical Investigation for the Evaluation of Efficacy and Safety of Two Medical Devices for the Treatment of Onychomycosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
Collaborators: name: Eurofins
First posted: 2024-02-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective of the study is to evaluate the effectiveness of FORTE (X92001873), ACTIVE COVER LIGHT (X92001872) and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline.

The secondary objectives are to evaluate:

* Their effectiveness in the treatment of onychomycosis based on the microbiological cure (KOH staining and fungal culture)
* Their effectiveness in the improvement of nail appearance (onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening)
* Their effectiveness in the improvement of the quality of life of the patients using a specific questionnaire.
* Their effectiveness, tolerance and acceptability based on patient's opinion.
* Their safety The aim of the study is to demonstrate non-inferiority of the change in healthy nail surface from baseline to D270 of each product (μD) versus a predefined limit of 16% (clinically meaningful: μC) with a non-inferiority margin of δ = -5%

Eligibility criteria: Inclusion Criteria:

1. Patient having given freely her/his informed, written consent.
2. Patient having a good general health.
3. Age: more than 18 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).
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.
9. Patient having stopped any topical antifungal treatment since at least 3 months before screening.
10. Patient who agrees 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.
11. 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: Percentage of healthy surface (Performance)
timeFrame: 270 days
Secondary outcomes:
measure: Percentage of healthy surface (Performance)
timeFrame: 30 days; 90 days; 180 days
measure: Microbiological efficacy: KOH staining (Performance)
timeFrame: 270 days (month 9)
measure: Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)
timeFrame: Baseline, 30 days; 90 days, 180 days; 270 days
measure: Clinical efficacy: onychomycosis evolution (Performance)
timeFrame: 30 days; 90 days; 180 days; 270 days
measure: Impact on quality of life (Performance)
timeFrame: Baseline, 30 days; 90 days, 180 days; 270 days
measure: Subjective evaluation questionnaire for the patient (Performance)
timeFrame: 14 days; 30 days; 90 days; 180 days; 270 days
measure: Evaluation of tolerance
timeFrame: 30 days; 90 days; 180 days; 270 days
Other outcomes:
Locations:
Study officials:
References: