Onychomycosis Clinical Trial
Verified date | June 2013 |
Source | Moberg Derma AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
Status | Completed |
Enrollment | 75 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
N/A
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Moberg Derma AB |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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