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Trial record 6 of 12 for:    "Tinea Unguium" | "Cytochrome P-450 Enzyme Inhibitors"

Efficacy and Safety of RV4104A Ointment in Onychomycosis

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: NCT00808366
Recruitment Status : Unknown
Verified December 2008 by Pierre Fabre Dermo Cosmetique.
Recruitment status was:  Recruiting
First Posted : December 15, 2008
Last Update Posted : December 15, 2008
Sponsor:
Information provided by:
Pierre Fabre Dermo Cosmetique

Tracking Information
First Submitted Date  ICMJE December 12, 2008
First Posted Date  ICMJE December 15, 2008
Last Update Posted Date December 15, 2008
Study Start Date  ICMJE October 2008
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs [ Time Frame: D21 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
  • Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation [ Time Frame: D21 ]
  • Patient self-assessment [ Time Frame: D21, D77, D105 ]
  • Clinical cure [ Time Frame: D77, D105 ]
  • Mycological cure [ Time Frame: D105 ]
  • Complete cure of onychomycosis [ Time Frame: D105 ]
  • Local tolerability [ Time Frame: D7, D21 ]
  • Adverse Event reporting [ Time Frame: Throughout the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of RV4104A Ointment in Onychomycosis
Official Title  ICMJE A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis
Brief Summary The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Drug: Keratolytic/Antifungal
    Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
  • Drug: Keratolytic/Antifungal
    Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Study Arms  ICMJE
  • Experimental: RV4104A ointment
    Intervention: Drug: Keratolytic/Antifungal
  • Active Comparator: bifonazole-urea ointment
    Intervention: Drug: Keratolytic/Antifungal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
  • Target nail plate showing ≥ 12.5% of clinically infected area
  • Patient must have at least 2 mm of the proximal end of the target nail free of infection
  • Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)

Exclusion Criteria:

  • Patient with more than 2 affected toenails
  • 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 topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808366
Other Study ID Numbers  ICMJE RV4104A2007593
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetique
Study Sponsor  ICMJE Pierre Fabre Dermo Cosmetique
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carle PAUL, Professor Hôpital Purpan, Toulouse - FRANCE
PRS Account Pierre Fabre Dermo Cosmetique
Verification Date December 2008

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