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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis | Drug: Keratolytic/Antifungal | Not Applicable |
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 |
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.
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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.
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- 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 ]
- 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 ]

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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

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
Contact: Marine Maigret, PhD | +33.5.62.48.85.92 | marine.maigret@pierre-fabre.com |
France | |
Hôpital Purpan | Recruiting |
Toulouse, France, 31059 |
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 |