EUCTR2009-011125-14-FR
Active, not recruiting
Phase 1
A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer alone for the treatment of dermatophytic onychomycosis (toenail) without matrix involvement - ONICO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pierre Fabre Dermatologie
- Enrollment
- 260
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relating to the population:
- •\-Over 18 year\-old male or female patient
- •\-Patient who has signed the informed consent form
- •\-Patient willing to attend the planned study visits at the investigational centre and to comply with all study requirements
- •\-If required by national regulations, patient must be registered with health social security or health insurance
- •\-Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
- •\-Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit
- •Relating to the disease:
- •\-Clinical diagnosis of distal\-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement
- •\-Target nail plate showing between 25% and 60% of clinically infected area
Exclusion Criteria
- •Relating to the population:
- •\-Female patient who is pregnant or planning a pregnancy during the course of the study or breast feeding
- •\-Patient who is unable to understand the information (for linguistic or psychiatric reasons) and to give his/her consent to participate
- •\-Patient who has forfeited his/her freedom by administrative or legal decision or under guardianship
- •\-Patient with known hypersensitivity to investigational products’ ingredient(s)
- •\-Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit
- •Relating to the disease:
- •\-Patient with more than 3 affected toenails
- •\- Patient with onychomycosis with matrix involvement
- •\-Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
Outcomes
Primary Outcomes
Not specified
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