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Clinical Trial of Topical ABL01 Treatment of Onychomycosis

NCT03141840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-02-20

No results posted yet for this study

Summary

This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.

Conditions

  • Onychomycosis of Toenail

Interventions

DEVICE

ABL01

Experimental medical device

DEVICE

Placebo

ABL01 lacking active component

Sponsors & Collaborators

  • Abbell AB

    lead INDUSTRY

Principal Investigators

  • Irini Mouratidou-Kontorinis · Fotcompaniet Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2019-02-08
Completion
2019-02-08

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141840 on ClinicalTrials.gov