ONICO: 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

Sponsor

Pierre Fabre Dermo Cosmetique (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01014637

Collaborator

Quanta Medical (Industry)

260

Enrollment

Locations

Arms

Duration (Months)

37.1

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Onychomycosis	Drug: Amorolfine (Antifungal) Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Amorolfine 5%	Drug: Amorolfine (Antifungal) Treatment with Amorolfine for 36 weeks Other Names: Loceryl
Experimental: RV4104A-cylcopiroxolamine-ciclopirox	Drug: 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. Other Names: RV4104A ointment Mycoster 1% Mycoster 8%

Arm

Intervention/Treatment

Active Comparator: Amorolfine 5%

Drug: Amorolfine (Antifungal)

Treatment with Amorolfine for 36 weeks

Other Names:

Loceryl

Experimental: RV4104A-cylcopiroxolamine-ciclopirox

Drug: 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.

Other Names:

RV4104A ointment

Mycoster 1%

Mycoster 8%

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
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]
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]
Averse Events Reporting [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cabinet Médical	Argenteuil	France	95100
2	Cabinet Médical	Brest	France	29200
3	Cabinet Medical	Cholet	France	49300
4	Cabinet Médical	Martigues	France	13500
5	Cabinet Médical	Nice	France	06000
6	Cabinet Médical	Toulouse	France	31000
7	Hopital Purpan	Toulouse	France