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Efficacy and Safety of RV4104A Ointment in Onychomycosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Pierre Fabre Dermo Cosmetique.
Recruitment status was:  Recruiting
Information provided by:
Pierre Fabre Dermo Cosmetique Identifier:
First received: December 12, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
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
Drug: Keratolytic/Antifungal

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 ]

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 ]
  • Patient self-assessment [ Time Frame: D21, D77, D105 ]
  • Clinical cure [ Time Frame: D77, D105 ]
  • Mycological cure [ Time Frame: D105 ]
  • Complete cure of onychomycosis [ Time Frame: D105 ]
  • Local tolerability [ Time Frame: D7, D21 ]
  • Adverse Event reporting [ Time Frame: Throughout the study ]

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00808366

Contact: Marine Maigret, PhD +

Hôpital Purpan Recruiting
Toulouse, France, 31059
Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
Principal Investigator: Carle PAUL, Professor Hôpital Purpan, Toulouse - FRANCE
  More Information

Responsible Party: Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetique Identifier: NCT00808366     History of Changes
Other Study ID Numbers: RV4104A2007593
Study First Received: December 12, 2008
Last Updated: December 12, 2008

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Antifungal Agents
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 processed this record on May 24, 2017