A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
This study has been completed.
Moberg Pharma AB
First Posted: August 12, 2010
Last Update Posted: June 26, 2013
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Further study details as provided by Moberg Pharma AB:
Primary Outcome Measures:
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.
Study Start Date:
Study Completion Date:
Primary Completion Date:
November 2010 (Final data collection date for primary outcome measure)
Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
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
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