Efficacy and Safety of RV4104A Ointment in Onychomycosis
NCT ID: NCT00808366
Last Updated: 2008-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
228 participants
INTERVENTIONAL
2008-10-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RV4104A ointment
Keratolytic/Antifungal
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
bifonazole-urea ointment
Keratolytic/Antifungal
Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Interventions
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Keratolytic/Antifungal
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Keratolytic/Antifungal
Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Responsible Party
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Pierre Fabre Dermo Cosmetique
Principal Investigators
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Carle PAUL, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Purpan, Toulouse - FRANCE
Locations
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Hôpital Purpan
Toulouse, , France
Countries
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Central Contacts
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Other Identifiers
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RV4104A2007593
Identifier Type: -
Identifier Source: org_study_id