A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

NCT ID: NCT01180491

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.

Conditions

Onychomycosis

Interventions

K101 nail solution

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moberg Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

K101-50

Identifier Type: -

Identifier Source: org_study_id