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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: Amorolfine (Antifungal)
* Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amorolfine 5%<br> | Drug: Amorolfine (Antifungal)<br>* Treatment with Amorolfine for 36 weeks<br>* Other names: Loceryl;|
| Experimental: RV4104A-cylcopiroxolamine-ciclopirox<br> | Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)<br>* 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.<br>* Other names: Mycoster 8%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious