Back to resultsA Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
K101 nail solution
Sponsored by
About this trial
This is an interventional trial for Onychomycosis focused on measuring Discoloured and deformed nails resulting from onychomycosis
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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01180491
Brief Title
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moberg Pharma AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Discoloured and deformed nails resulting from onychomycosis
7. Study Design
Study Phase
Not Applicable
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
K101 nail solution
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
12. IPD Sharing Statement
Learn more about this trial
A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
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