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
Recruitment status was Recruiting
Sponsor:
Pierre Fabre Dermo Cosmetique
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
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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:
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
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 ClinicalTrials.gov identifier: NCT00808366
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:
|
Nail Diseases Onychomycosis Dermatomycoses Infection Mycoses Skin Diseases Skin Diseases, Infectious Tinea Antifungal Agents Bifonazole |
Keratolytic Agents Miconazole 14-alpha Demethylase Inhibitors Anti-Infective Agents Dermatologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015