Recruiting
Phase 2

CELEXT07

Sponsor:

9305-9954 Quebec Inc

Code:

NCT02644551

Conditions

Onychomycosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CELEXT07

Penlac

vehicle solution

Study Details

Brief 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

Study ID

NCT02644551

Start date

Nov, 2016

Status verified date

Apr, 2017

Completion date

Sep, 2018

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects are eligible to be included in the study only if they meet all of the following criteria:

1. Age > 18.
2. Clinically diagnosed onychomycosis of the target nail.
3. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
4. Has a positive KOH examination from the target nail.
5. Has a positive dermatophyte culture from the target nail.
6. Written informed consent obtained.
7. Subject agreed to follow the protocol.

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:

1. Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
2. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
3. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
4. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
5. Inability to understand and comply with the instructions of the study
6. Patients less than age 18
7. Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CELEXT07

suspension that is applied topically to the infected nail(s) daily.

placebo comparator: placebo

placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.

active comparator: Penlac

Is a standard of care for the condition and is applied topically to the infected nail(s) daily.

Interventions

CELEXT07

Penlac

vehicle solution

Primary outcome measure

  • Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks [ Time Frame: week 52 ]

Central Contacts and Locations

Central contacts

Liza Lymberopoulos

514-254-5000

Locations

Clinique podiatrique de Montréal

Recruiting

Montreal, Quebec, Canada, H1X 2B3

Contacts

More Information

Sponsor

9305-9954 Quebec Inc

Last update posted

Apr 26, 2017

Last verified

Apr, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 9305-9954 Quebec Inc on 2017-04-26.