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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01180491
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):
Moberg Pharma AB

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

Condition or disease Intervention/treatment Phase
Onychomycosis Device: K101 nail solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Responsible Party: Moberg Pharma AB Identifier: NCT01180491     History of Changes
Other Study ID Numbers: K101-50
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Moberg Pharma AB:
Discoloured and deformed nails resulting from onychomycosis

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases