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

This study has been completed.

Sponsor:

Information provided by:

Moberg Derma AB

ClinicalTrials.gov Identifier:

NCT01180491

First received: August 10, 2010

Last updated: May 23, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 10, 2010
Last Updated Date	May 23, 2011
Start Date ^ICMJE	September 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 11, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01180491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Onychomycosis
Intervention ^ICMJE	Device: K101 nail solution
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	70
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01180491
Other Study ID Numbers ^ICMJE	K101-50
Has Data Monitoring Committee	No
Responsible Party	Kjell Rensfeldt MD, Moberg Derma AB
Study Sponsor ^ICMJE	Moberg Derma AB
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Moberg Derma AB
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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