Onychomycosis
Conditions
Keywords
Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious
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.
Interventions
DRUGAmorolfine (Antifungal)
Treatment with Amorolfine for 36 weeks
DRUGRV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.
Sponsors
Quanta Medical
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
Primary ContactJean-Jacques VOISARD, MD
Backup ContactHéla COUBETERGUES
Outcome results
None listed