CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enriched, Loceryl 5%.
- Who it may be relevant to
- Registry conditions: Onychomycosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
Overview
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).
Interventions
- Device Enriched
To be used twice a day - Drug Loceryl 5%
To be used once a week
Primary outcome measures
- Blinded evaluation of the percentage of healthy nail surface [Time frame: 270 days]
Secondary outcome measures (7)
- Percentage of healthy surface (performance) [Time frame: 90 days, 180 days]
- Mirobiological efficacy ; KOH staining (Performance) [Time frame: 270 days]
- Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance) [Time frame: 90 days, 180 days, 270 days]
- Clinical efficacy: onychomycosis evolution (Performance) [Time frame: 90 days, 180 days, 270 days]
- Impact on quality of life (Performance) [Time frame: 180 days, 270 days]
- Subjective evaluation questionnaire for the patient (Performance) [Time frame: 14 days, 90 days, 180 days, 270 days]
- Evaluation of tolerance [Time frame: 90 days, 180 days, 270 days]
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 \<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…).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Eurofins Dermscan Pharmascan — Villeurbanne
Identifiers
NCT: NCT06689852 · 23E1728