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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180491

Enrollment

Registered

2010-08-12

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2013-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Keywords

Discoloured and deformed nails resulting from onychomycosis

Brief summary

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

Interventions

DEVICEK101 nail solution

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026