Trials / Unknown
UnknownNCT02644551
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- 9305-9954 Quebec Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CELEXT07 | |
| DRUG | Penlac | |
| OTHER | vehicle solution |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-05-01
- Completion
- 2018-09-01
- First posted
- 2016-01-01
- Last updated
- 2017-04-26
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02644551. Inclusion in this directory is not an endorsement.