A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
June 25, 2013 updated by: Moberg Pharma AB
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
Study Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
August 10, 2010
First Submitted That Met QC Criteria
August 11, 2010
First Posted (Estimate)
August 12, 2010
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 25, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K101-50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.