Back to resultsEfficacy and Safety of RV4104A Ointment in Onychomycosis
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Keratolytic/Antifungal
Keratolytic/Antifungal
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
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
Sites / Locations
- Hôpital PurpanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RV4104A ointment
bifonazole-urea ointment
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Patient self-assessment
Clinical cure
Mycological cure
Complete cure of onychomycosis
Local tolerability
Adverse Event reporting
Full Information
NCT ID
NCT00808366
First Posted
December 12, 2008
Last Updated
December 12, 2008
Sponsor
Pierre Fabre Dermo Cosmetique
1. Study Identification
Unique Protocol Identification Number
NCT00808366
Brief Title
Efficacy and Safety of RV4104A Ointment in Onychomycosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pierre Fabre Dermo Cosmetique
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RV4104A ointment
Arm Type
Experimental
Arm Title
bifonazole-urea ointment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Keratolytic/Antifungal
Intervention Description
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Keratolytic/Antifungal
Intervention Description
Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Patient self-assessment
Time Frame
D21, D77, D105
Title
Clinical cure
Time Frame
D77, D105
Title
Mycological cure
Time Frame
D105
Title
Complete cure of onychomycosis
Time Frame
D105
Title
Local tolerability
Time Frame
D7, D21
Title
Adverse Event reporting
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marine Maigret, PhD
Phone
+33.5.62.48.85.92
Email
marine.maigret@pierre-fabre.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carle PAUL, Professor
Organizational Affiliation
Hôpital Purpan, Toulouse - FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of RV4104A Ointment in Onychomycosis
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