Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
NCT ID: NCT01246518
Last Updated: 2012-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2010-12-31
2012-10-31
Brief Summary
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The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MOB015 for 3 months
MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
MOB015 for 9 months
MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
Interventions
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MOB015
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
Eligibility Criteria
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Inclusion Criteria
2. 18 - 70 years
3. DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
4. Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
5. Signed written informed consent
Exclusion Criteria
2. 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)
3. "Spike" of onychomycosis extending to eponychium of the target nail
4. 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
5. Other conditions than DSO known to cause abnormal nail appearance
6. Topical antifungal treatment of the nails within 1 month before screening
7. Systemic use of antifungal treatment within 3 months before screening
8. Signs of severe peripheral circulatory insufficiency
9. Immunosuppression
10. Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
11. Known allergy to any of the tested treatment products
12. A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
13. 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
18 Years
70 Years
ALL
No
Sponsors
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Moberg Pharma AB
INDUSTRY
Responsible Party
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Moberg Derma AB
Principal Investigators
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Jan Faergemann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden
Locations
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15 Locations
Sweden, , Sweden
Countries
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Other Identifiers
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MOB015-I
Identifier Type: -
Identifier Source: org_study_id