Clinical trial NCT01014637: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Onychomycosis
Keywords: Dermatomycoses
Infection
Mycoses
Nail diseases
Ski diseases
Skin diseases/infectious
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
Collaborators: name: Quanta Medical
First posted: 2009-11-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 336
Secondary outcomes:
measure: 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
timeFrame: Day 21, Day 77, Day 156, Day 262
measure: 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
timeFrame: Day 336
measure: 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
timeFrame: Day 77, Day 168, Day 252
measure: Averse Events Reporting
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Cabinet Médical
city: Brest
country: France
facility: Cabinet Médical
city: Cholet
country: France
facility: Cabinet Medical
city: Martigues
country: France
facility: Cabinet Médical
city: Nice
country: France
facility: Cabinet Médical
city: Toulouse
country: France
facility: Cabinet Médical
city: Toulouse
country: France
facility: Hopital Purpan
Study officials:
affiliation: Hopital Purpan
name: Carle PAUL, Professor
role: PRINCIPAL_INVESTIGATOR
References: