Efficacy and Safety of RV4104A Ointment in Onychomycosis

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Dermo Cosmetique
• Treatments: Antifungal Agents; Bifonazole; Clotrimazole; Keratolytic Agents; Miconazole

Criteria

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