Efficacy and Safety of RV4104A Ointment in Onychomycosis

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00808366
• Other study ID #: RV4104A2007593
• 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

• Onychomycosis

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