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

N/ACompletedNCT01180491

Moberg Pharma AB75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Enrollment

Conditions

Onychomycosis

Interventions

K101 nail solutionDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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