Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Dermo Cosmetique
• Collaborator: Quanta Medical
• Treatments: Amorolfine; Antifungal Agents; Ciclopirox; Clotrimazole; Keratolytic Agents; Miconazole

Criteria

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