Status:
COMPLETED
Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
Lead Sponsor:
Moberg Pharma AB
Conditions:
Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 infecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01246518
Start Date
December 1 2010
End Date
October 1 2012
Last Update
October 25 2012
Active Locations (1)
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1
15 Locations
Sweden, Sweden