Efficacy and Safety of RV4104A Ointment in Onychomycosis
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
1 other identifier
interventional
228
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedDecember 15, 2008
December 1, 2008
8 months
December 12, 2008
December 12, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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
D21
Secondary Outcomes (7)
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
D21
Patient self-assessment
D21, D77, D105
Clinical cure
D77, D105
Mycological cure
D105
Complete cure of onychomycosis
D105
- +2 more secondary outcomes
Study Arms (2)
RV4104A ointment
EXPERIMENTALbifonazole-urea ointment
ACTIVE COMPARATORInterventions
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Purpan
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carle PAUL, Professor
Hôpital Purpan, Toulouse - FRANCE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2008
First Posted
December 15, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2009
Study Completion
October 1, 2009
Last Updated
December 15, 2008
Record last verified: 2008-12