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

Study Timeline

• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

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.