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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

NCT01014637 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2009-11-17

No results posted yet for this study

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.

Conditions

  • Onychomycosis

Interventions

DRUG

Amorolfine (Antifungal)

Treatment with Amorolfine for 36 weeks

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.

Sponsors & Collaborators

  • Quanta Medical

    collaborator INDUSTRY

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Carle PAUL, Professor · Hopital Purpan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014637 on ClinicalTrials.gov