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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:
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
  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 Derma 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.

Estimated Enrollment: 70
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Kjell Rensfeldt MD, Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01180491     History of Changes
Other Study ID Numbers: K101-50
Study First Received: August 10, 2010
Last Updated: May 23, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013