Efficacy and Safety of RV4104A Ointment in Onychomycosis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.

Official Title
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A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: Keratolytic/Antifungal
* Drug: Keratolytic/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) Target nail plate showing ≥ 12.5% of clinically infected area Patient must have at least 2 mm of the proximal end of the target nail free of infection Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory) Exclusion Criteria: Patient with more than 2 affected toenails 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 topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months 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 |
| --- | --- |
| Experimental: RV4104A ointment<br> | Drug: Keratolytic/Antifungal<br>* Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.<br>|
| Active Comparator: bifonazole-urea ointment<br> | Drug: Keratolytic/Antifungal<br>* Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs |  | D21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation |  | D21 | 
| Patient self-assessment |  | D21, D77, D105 | 
| Clinical cure |  | D77, D105 | 
| Mycological cure |  | D105 | 
| Complete cure of onychomycosis |  | D105 | 
| Local tolerability |  | D7, D21 | 
| Adverse Event reporting |  | Throughout the study |