Trial | NCT01014637  Report issue

Title

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
A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Amorolfine ciclopirox ...

  • Study Participants

    260
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.
Study Started
Aug 31
2009
Primary Completion
Sep 30
2011
Anticipated
Study Completion
Sep 30
2011
Anticipated
Last Update
Nov 17
2009
Estimate

Drug Amorolfine (Antifungal)

Treatment with Amorolfine for 36 weeks

  • Other names: Loceryl

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

Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.

  • Other names: RV4104A ointment, Mycoster 1%, Mycoster 8%

Amorolfine 5% Active Comparator

RV4104A-cylcopiroxolamine-ciclopirox Experimental

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
No Results Posted