Onychomycosis
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.
Interventions
DRUGKeratolytic/Antifungal
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Sponsors
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) * Target nail plate showing ≥ 12.5% of clinically infected area * Patient must have at least 2 mm of the proximal end of the target nail free of infection * Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)
Exclusion criteria
* Patient with more than 2 affected toenails * 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 topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs | D21 |
Secondary
| Measure | Time frame |
|---|---|
| Patient self-assessment | D21, D77, D105 |
| Clinical cure | D77, D105 |
| Mycological cure | D105 |
| Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation | D21 |
| Local tolerability | D7, D21 |
| Adverse Event reporting | Throughout the study |
| Complete cure of onychomycosis | D105 |
Countries
France
Contacts
Primary ContactMarine Maigret, PhD
Outcome results
None listed