Skip to main content
OpenTrials
Completed

NCT Number: NCT01180491

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K101 nail solution

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Moberg Pharma AB

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 12, 2010
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.