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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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: Bifonazole

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
RV4104A ointment: Experimental	Drug: Keratolytic/Antifungal Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
bifonazole-urea ointment: Active Comparator	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:	Pierre Fabre Dermo Cosmetique ( Anne-Marie Schmitt, MD )
Study ID Numbers:	RV4104A2007593
Study First Received:	December 12, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00808366 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Anti-Infective Agents
Skin Diseases
Infection
Pharmacologic Actions
Keratolytic Agents
Mycoses
Skin Diseases, Infectious

Onychomycosis
Nail Diseases
Antifungal Agents
Therapeutic Uses
Dermatologic Agents
Tinea
Dermatomycoses

ClinicalTrials.gov processed this record on February 08, 2010