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Efficacy and Safety of RV4104A Ointment in Onychomycosis

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ClinicalTrials.gov Identifier: NCT00808366
Recruitment Status : Unknown
Verified December 2008 by Pierre Fabre Dermo Cosmetique.
Recruitment status was:  Recruiting
First Posted : December 15, 2008
Last Update Posted : December 15, 2008
Sponsor:
Information provided by:
Pierre Fabre Dermo Cosmetique

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
Onychomycosis Drug: Keratolytic/Antifungal

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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    Key Record Dates
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