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

Moberg Pharma

Status: Completed

Conditions: Onychomycosis

Treatments: Device: K101 nail solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180491

K101-50

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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