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Efficacy and Safety of RV4104A Ointment in Onychomycosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Pierre Fabre Dermo Cosmetique.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:
NCT00808366
First received: December 12, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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:

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Tinea
Onychomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Antifungal Agents
Clotrimazole
Miconazole
 Bifonazole
Keratolytic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013