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

Onychomycosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180491
• Other study ID #: K101-50
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: June 25, 2013
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2013
• Source: Moberg Derma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• K101 nail solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moberg Derma AB

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.