Trials / Recruiting
RecruitingNCT06689852
CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- Sponsor
- Oystershell NV · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Enriched | To be used twice a day |
| DRUG | Loceryl 5% | To be used once a week |
Timeline
- Start date
- 2024-10-30
- Primary completion
- 2025-07-04
- Completion
- 2026-04-01
- First posted
- 2024-11-15
- Last updated
- 2025-09-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06689852. Inclusion in this directory is not an endorsement.