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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00808366
Other study ID # RV4104A2007593
Secondary ID
Status Recruiting
Phase N/A
First received December 12, 2008
Last updated December 12, 2008
Start date October 2008
Est. completion date October 2009

Study information

Verified date December 2008
Source Pierre Fabre Dermo Cosmetique
Contact Marine Maigret, PhD
Phone +33.5.62.48.85.92
Email marine.maigret@pierre-fabre.com
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 228
Est. completion date October 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
France Hôpital Purpan Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 D21 No
Secondary 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 D21 No
Secondary Patient self-assessment D21, D77, D105 No
Secondary Clinical cure D77, D105 No
Secondary Mycological cure D105 No
Secondary Complete cure of onychomycosis D105 No
Secondary Local tolerability D7, D21 Yes
Secondary Adverse Event reporting Throughout the study Yes
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