Efficacy and Safety of RV4104A Ointment in Onychomycosis
Information source: Pierre Fabre Dermo Cosmetique
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onychomycosis
Intervention: Keratolytic/Antifungal (Drug); Keratolytic/Antifungal (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Pierre Fabre Dermo Cosmetique Official(s) and/or principal investigator(s):
Carle PAUL, Professor, Principal Investigator, Affiliation: Hôpital Purpan, Toulouse - FRANCE
Overall contact:
Marine Maigret, PhD, Phone: +33.5.62.48.85.92, Email: marine.maigret@pierre-fabre.com
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluationPatient self-assessment Clinical cure Mycological cure Complete cure of onychomycosis Local tolerability Adverse Event reporting
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Marine Maigret, PhD, Phone: +33.5.62.48.85.92, Email: marine.maigret@pierre-fabre.com
Hôpital Purpan, Toulouse 31059, France; Recruiting
Additional Information
Starting date: October 2008
Ending date: October 2009
Last updated: December 12, 2008
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