Status:
UNKNOWN
Efficacy and Safety of RV4104A Ointment in Onychomycosis
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Onychomycosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00808366
Start Date
October 1 2008
End Date
October 1 2009
Last Update
December 15 2008
Active Locations (1)
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1
Hôpital Purpan
Toulouse, France, 31059