The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: CELEXT07
* Drug: Penlac
* Other: vehicle solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible to be included in the study only if they meet all of the following criteria: Age > 18. Clinically diagnosed onychomycosis of the target nail. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected. Has a positive KOH examination from the target nail. Has a positive dermatophyte culture from the target nail. Written informed consent obtained. Subject agreed to follow the protocol. Exclusion Criteria Subjects will be excluded from the study if they meet any of the following criteria: Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. Inability to understand and comply with the instructions of the study Patients less than age 18 Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CELEXT07<br>suspension that is applied topically to the infected nail(s) daily. | Drug: CELEXT07<br> <br> |
| Placebo Comparator: placebo<br>placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily. | Other: vehicle solution<br> <br> * Other names: placebo;|
| Active Comparator: Penlac<br>Is a standard of care for the condition and is applied topically to the infected nail(s) daily. | Drug: Penlac<br> <br> * Other names: topical Penlac nail lacquer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks | Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as Yes if: Mycological cure (negative KOH and negative culture for dermatophytes) and No residual involvement of the target toenail No if otherwise | week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks. | Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.Clinical effectiveness is a composite binary variable defined as Yes if Mycological cure (negative KOH and negative culture for dermatophytes) and ◦= 10% residual involvement of the target toenail No if otherwise | week 52 | 
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks. | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure is a composite binary variable defined as Yesif : Negative microscopy and Negative culture for dermatophytes No if otherwise. | week 52 | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | week 52 |