ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01014637
Recruitment Status : Unknown
Verified November 2009 by Pierre Fabre Dermo Cosmetique.
Recruitment status was:  Recruiting
First Posted : November 17, 2009
Last Update Posted : November 17, 2009
Sponsor:
Collaborator:
Quanta Medical
Information provided by:
Pierre Fabre Dermo Cosmetique

November 16, 2009
November 17, 2009
November 17, 2009
August 2009
September 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
  • 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 ]
  • 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 ]
  • Averse Events Reporting [ Time Frame: Throughout the study ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Onychomycosis
  • Drug: Amorolfine (Antifungal)
    Treatment with Amorolfine for 36 weeks
    Other Name: 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%
  • Active Comparator: Amorolfine 5%
    Intervention: Drug: Amorolfine (Antifungal)
  • Experimental: RV4104A-cylcopiroxolamine-ciclopirox
    Intervention: Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
260
Same as current
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01014637
RV4104A 2008 548
No
Not Provided
Not Provided
Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetiques
Pierre Fabre Dermo Cosmetique
Quanta Medical
Principal Investigator: Carle PAUL, Professor Hopital Purpan
Pierre Fabre Dermo Cosmetique
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP