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 (Responsible Party):
Moberg Derma AB
ClinicalTrials.gov Identifier:
NCT01180491
First received: August 10, 2010
Last updated: June 25, 2013
Last verified: June 2013
  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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01180491     History of Changes
Other Study ID Numbers: K101-50
Study First Received: August 10, 2010
Last Updated: June 25, 2013
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 July 29, 2014