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
ONICO
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
1 other identifier
interventional
260
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2009
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 16, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedNovember 17, 2009
November 1, 2009
2.1 years
November 16, 2009
November 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Amorolfine 5%
ACTIVE COMPARATORRV4104A-cylcopiroxolamine-ciclopirox
EXPERIMENTALInterventions
Treatment with Amorolfine for 36 weeks
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pierre Fabre Dermo Cosmetiquelead
- Quanta Medicalcollaborator
Study Sites (7)
Cabinet Médical
Argenteuil, 95100, France
Cabinet Médical
Brest, 29200, France
Cabinet Medical
Cholet, 49300, France
Cabinet Médical
Martigues, 13500, France
Cabinet Médical
Nice, 06000, France
Cabinet Médical
Toulouse, 31000, France
Hopital Purpan
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carle PAUL, Professor
Hopital Purpan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 16, 2009
First Posted
November 17, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
November 17, 2009
Record last verified: 2009-11