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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amorolfine 5%

Group Type ACTIVE_COMPARATOR

Amorolfine (Antifungal)

Intervention Type DRUG

Treatment with Amorolfine for 36 weeks

RV4104A-cylcopiroxolamine-ciclopirox

Group Type EXPERIMENTAL

RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)

Intervention Type DRUG

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.

Interventions

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Amorolfine (Antifungal)

Treatment with Amorolfine for 36 weeks

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Loceryl RV4104A ointment Mycoster 1% Mycoster 8%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No