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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOB015 for 3 months | Active Comparator |
| |
| MOB015 for 9 months | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOB015 | Drug | Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with negative fungal culture, negative direct microscopy and complete cure. | 1, 3, 6, 9, 12 months. |
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Inclusion Criteria:
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 :
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| Name | Affiliation | Role |
|---|---|---|
| Jan Faergemann, MD, PhD | Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 15 Locations | Sweden | Sweden |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |