Efficacy and Safety of RV4104A Ointment in Onychomycosis - Full Text View

Sponsor:	Pierre Fabre Dermo Cosmetique
Information provided by:	Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:	NCT00808366

Purpose

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.

Condition	Intervention
Onychomycosis	Drug: Keratolytic/Antifungal

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Carbamide Bifonazole Carbamide peroxide

U.S. FDA Resources

Further study details as provided by Pierre Fabre Dermo Cosmetique:

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 [ Time Frame: D21 ] [ Designated as safety issue: No ]

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 [ Time Frame: D21 ] [ Designated as safety issue: No ]
Patient self-assessment [ Time Frame: D21, D77, D105 ] [ Designated as safety issue: No ]
Clinical cure [ Time Frame: D77, D105 ] [ Designated as safety issue: No ]
Mycological cure [ Time Frame: D105 ] [ Designated as safety issue: No ]
Complete cure of onychomycosis [ Time Frame: D105 ] [ Designated as safety issue: No ]
Local tolerability [ Time Frame: D7, D21 ] [ Designated as safety issue: Yes ]
Adverse Event reporting [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	228
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RV4104A ointment	Drug: Keratolytic/Antifungal Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Active Comparator: bifonazole-urea ointment	Drug: Keratolytic/Antifungal Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808366

Contacts

Contact: Marine Maigret, PhD

+33.5.62.48.85.92

marine.maigret@pierre-fabre.com

Locations

France
Hôpital Purpan	Recruiting
Toulouse, France, 31059

Sponsors and Collaborators

Pierre Fabre Dermo Cosmetique

Investigators

Principal Investigator:

Carle PAUL, Professor

Hôpital Purpan, Toulouse - FRANCE

More Information

No publications provided

Responsible Party:	Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:	NCT00808366 History of Changes
Other Study ID Numbers:	RV4104A2007593
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

Antifungal Agents
Bifonazole
Keratolytic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012