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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:
ClinicalTrials.gov Identifier:
NCT01180491
First Posted: August 12, 2010
Last Update Posted: June 26, 2013
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.
Information provided by (Responsible Party):
Moberg Pharma AB
  Purpose
The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.

Condition Intervention
Onychomycosis Device: K101 nail solution

Study Type: Interventional

Further study details as provided by Moberg Pharma AB:

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.

Enrollment: 75
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Moberg Pharma AB
ClinicalTrials.gov Identifier: NCT01180491     History of Changes
Other Study ID Numbers: K101-50
First Submitted: August 10, 2010
First Posted: August 12, 2010
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:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases