A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
Not Applicable
Completed
- Conditions
- Onychomycosis
- Registration Number
- NCT01180491
- Lead Sponsor
- Moberg Pharma AB
- Brief Summary
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Male or female patients aged 18 years or older
- 25%-75% of the target nail altered as a result of onychomycosis
- Signed written informed consent
Exclusion criteria
- Proximal subungual onychomycosis
- Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
- Other conditions known to cause abnormal nail appearance
- Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
- Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
- Known allergy to any of the tested treatment products
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing at least some improvement of the target nail (scoring 2 or more according to Global Assessment Scale) after 8 weeks treatment.
- Secondary Outcome Measures
Name Time Method