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Efficacy and Safety of RV4104A Ointment in Onychomycosis

NCT00808366 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2008-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Onychomycosis

Interventions

DRUG

Keratolytic/Antifungal

Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.

DRUG

Keratolytic/Antifungal

Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Carle PAUL, Professor · Hôpital Purpan, Toulouse - FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808366 on ClinicalTrials.gov