Efficacy and Safety of RV4104A Ointment in Onychomycosis

Pierre Fabre

Status: Unknown

Conditions: Onychomycosis

Treatments: Drug: Keratolytic/Antifungal

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808366

RV4104A2007593

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

RV4104A ointment

Experimental group

Treatment:

Drug: Keratolytic/Antifungal

Drug: Keratolytic/Antifungal

bifonazole-urea ointment

Active Comparator group

Treatment:

Drug: Keratolytic/Antifungal

Drug: Keratolytic/Antifungal