Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis

Onychomycosis Clinical Trial

— ONICO  

Official title:

A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01014637
• Other study ID #: RV4104A 2008 548
• Status: Recruiting
• Phase: Phase 4
• First received: November 16, 2009
• Last updated: November 16, 2009
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: November 2009
• Source: Pierre Fabre Dermo Cosmetique
• Contact: Jean-Jacques VOISARD, MD
• Phone: +33 5 63 58 88 00
• Email: jean.jacques.voisard[@]pierre-fabre.com
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• 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) without matrix involvement

• Target nail plate showing between 25% and 60% of clinically infected area

• Patient must have at least 2 mm of unaffected proximal target nail area

• Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)

• Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit

• Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit

Exclusion Criteria:

• Patient with more than 3 affected nails

• Patient with onychomycosis with matrix involvement

• 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 any topical antifungal therapy applied to the toenails within 3 months prior to screening visit

• Patient with known hypersensitivity to investigational products' ingredient(s)

• Patient who is currently participating or who has participated in another clinical study within 4 weeks 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:
• Amorolfine (Antifungal)
Treatment with Amorolfine for 36 weeks
• RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.

Locations

Country	Name	City	State
France	Cabinet Médical	Argenteuil
France	Cabinet Médical	Brest
France	Cabinet Medical	Cholet
France	Cabinet Médical	Martigues
France	Cabinet Médical	Nice
France	Cabinet Médical	Toulouse
France	Hopital Purpan	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique	Quanta Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement		Day 336	No
Secondary	To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement		Day 21, Day 77, Day 156, Day 262	Yes
Secondary	To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement		Day 336	No
Secondary	To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement		Day 77, Day 168, Day 252	No
Secondary	Averse Events Reporting		Throughout the study	Yes