Efficacy and Safety of RV4104A Ointment in Onychomycosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Onychomycosis	Drug: Keratolytic/Antifungal	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	228 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	October 2008
Estimated Primary Completion Date :	June 2009
Estimated Study Completion Date :	October 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 [ Time Frame: D21 ]

Secondary Outcome Measures :

1. 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 ]
2. Patient self-assessment [ Time Frame: D21, D77, D105 ]
3. Clinical cure [ Time Frame: D77, D105 ]
4. Mycological cure [ Time Frame: D105 ]
5. Complete cure of onychomycosis [ Time Frame: D105 ]
6. Local tolerability [ Time Frame: D7, D21 ]
7. Adverse Event reporting [ Time Frame: Throughout the study ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:	NCT00808366 History of Changes
Other Study ID Numbers:	RV4104A2007593
First Posted:	December 15, 2008
Last Update Posted:	December 15, 2008
Last Verified:	December 2008

Additional relevant MeSH terms:

Onychomycosis; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Skin Diseases; Antifungal Agents; Miconazole; Bifonazole; Keratolytic Agents	Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Dermatologic Agents