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)

November 16, 2009 updated by: Pierre Fabre Dermo Cosmetique

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Yves LE CORRE, MD
      • Brest, France, 29200
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Monique CHASSAIN LE LAY, MD
      • Cholet, France, 49300
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Jean-Michel DEBARRE, MD
      • Martigues, France, 13500
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Mireille RUER-MULLARD, MD
      • Nice, France, 06000
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Gilles ROSTAIN, MD
      • Toulouse, France, 31000
        • Recruiting
        • Cabinet Medical
        • Principal Investigator:
          • Didier COUSTOU, MD
      • Toulouse, France
        • Not yet recruiting
        • Hopital Purpan
        • Principal Investigator:
          • Carle PAUL, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amorolfine 5%
Drug: Amorolfine (Antifungal)
Treatment with Amorolfine for 36 weeks
Other Names:
  • Loceryl
Experimental: RV4104A-cylcopiroxolamine-ciclopirox
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
Time Frame: Day 336
Day 336

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time Frame: Day 21, Day 77, Day 156, Day 262
Day 21, Day 77, Day 156, Day 262
To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement
Time Frame: Day 336
Day 336
To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time Frame: Day 77, Day 168, Day 252
Day 77, Day 168, Day 252
Averse Events Reporting
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Dermo Cosmetique

Collaborators

Quanta Medical

Investigators

  • Principal Investigator: Carle PAUL, Professor, Hopital Purpan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV4104A 2008 548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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