Informations générales (source: ClinicalTrials.gov)

NCT00808366 Statut inconnu
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
Interventional
  • Onychomycose
N/A
Pierre Fabre Dermo Cosmetique (Voir sur ClinicalTrials)
octobre 2008
octobre 2009
29 juin 2024
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Purpan - 31059 - Toulouse - France En recrutement Contact (sur clinicalTrials)

Critères

Tous
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)


- 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