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The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

NCT02644551 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-04-26

No results posted yet for this study

Summary

This will be an interventional safety and efficacy study of CELENT07 when used as a topical treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This is randomized, double-blind, parallel design, placebo and active controlled study in patients with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for 52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical efficacy and safety and tolerability.

Conditions

  • Onychomycosis

Interventions

DRUG

CELEXT07

DRUG

Penlac

OTHER

vehicle solution

Sponsors & Collaborators

  • 9305-9954 Quebec Inc

    lead INDUSTRY

Principal Investigators

  • Céline Devaux, MD, FRCPC · 9305-9954 Quebec Inc

  • Guy Chamberland, M.Sc., Ph.D. · 9305-9954 Quebec Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-05-31
Completion
2018-09-30

Countries

  • Canada

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 NCT02644551 on ClinicalTrials.gov