Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis
Phase 4
- Conditions
- Onychomycosis
- Interventions
- Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
- Registration Number
- NCT01014637
- Lead Sponsor
- Pierre Fabre Dermo Cosmetique
- Brief Summary
The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
- 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
- Patient must have at least 2 mm of unaffected proximal target nail area
- Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
- 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
Exclusion Criteria
- Patient with more than 3 affected nails
- Patient with onychomycosis with matrix involvement
- Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
- Patient with moccasin-type tinea pedis
- Patient who has received systemic antifungal therapy or any topical antifungal therapy applied to the toenails within 3 months prior to screening visit
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amorolfine 5% Amorolfine (Antifungal) - RV4104A-cylcopiroxolamine-ciclopirox RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) -
- Primary Outcome Measures
Name Time Method To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement Day 336
- Secondary Outcome Measures
Name Time Method To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement Day 21, Day 77, Day 156, Day 262 To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement Day 336 To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement Day 77, Day 168, Day 252 Averse Events Reporting Throughout the study
Trial Locations
- Locations (3)
Cabinet MĂ©dical
🇫🇷Toulouse, France
Hopital Purpan
🇫🇷Toulouse, France
Cabinet Medical
🇫🇷Cholet, France