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

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.

Study Overview

• Status: Unknown
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: Keratolytic/Antifungal; Drug: Keratolytic/Antifungal

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marine Maigret, PhD; Phone Number: +33.5.62.48.85.92; Email: marine.maigret@pierre-fabre.com

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Hopital Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RV4104A ointment	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.
Active Comparator: bifonazole-urea ointment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Local tolerability	D7, D21
Adverse Event reporting	Throughout the study

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Carle PAUL, Professor, Hôpital Purpan, Toulouse - FRANCE

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 15, 2008
• Last Update Submitted That Met QC Criteria: December 12, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Antifungal Agents; Clotrimazole; Miconazole; Keratolytic Agents
• Other Study ID Numbers: RV4104A2007593