Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis

Study Overview
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Brief Summary
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Onychomycosis is a fungal infection that affects fingernails and/or toenails. The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.

Official Title
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An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: MOB015


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 - 70 years DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization) Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes) Signed written informed consent Exclusion Criteria: Proximal subungual onychomycosis DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm) Spike of onychomycosis extending to eponychium of the target nail Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail Other conditions than DSO known to cause abnormal nail appearance Topical antifungal treatment of the nails within 1 month before screening Systemic use of antifungal treatment within 3 months before screening Signs of severe peripheral circulatory insufficiency Immunosuppression Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening Known allergy to any of the tested treatment products A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1) Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who : are pregnant or nursing are not surgically sterile are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: MOB015 for 3 months<br> | Drug: MOB015<br>* Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.<br>|
| Active Comparator: MOB015 for 9 months<br> | Drug: MOB015<br>* Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with negative fungal culture, negative direct microscopy and complete cure. |  | 1, 3, 6, 9, 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal subungual onychomycosis