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 (ONICO)

Pierre Fabre

Status and phase

Unknown

Phase 4

Conditions

Onychomycosis

Treatments

Drug: Amorolfine (Antifungal)

Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014637

RV4104A 2008 548

Details and patient eligibility

About

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.

Enrollment

260 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) 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