Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

Study Overview
=================
Brief Summary
-----------------
There is a major clinical need for an inexpensive topically-applied product that can inhibit the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE with a longer drying/curing time that will allow better nail penetration or adsorption. Though the product may have inherent antimicrobial activity, the product does not contain a drug or antimicrobial agent. Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail fungal infection is defined by negative dermatophyte culture and visual improvement in nail characteristics within six months, with few, if any product-related adverse events.

Official Title
-----------------
Evaluation of the Efficacy of Chesson Labs LIQUICURE™ for Treatment of Onychomycosis

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

Intervention / Treatment
-----------------
* Device: LIQUICURE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nail fungal infection of at least one great toe [per visual assessment, positive KOH preparation, and positive dermatophyte culture] Subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator 2 mm of clear nail proximally on great toenail / no lunula involvement Subject must be physically able to reach toes to clean them and apply product Subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study Subject is willing and available to return for study follow up Ability of the subject or legal representative to understand and provide signed consent for participating in the study Negative urine pregnancy test for women of child bearing age Females must be post menopausal or must agree to use approved contraceptives (actions, devices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (Note: abstinence is NOT an accepted form of contraception) Exclusion Criteria: Known hypersensitivity or allergy to the product materials Negative KOH preparation or dermatophyte culture Thickness of nail greater than 3 mm Enrollment in another investigational drug or product protocol that would interfere with this study Continuation or use of other topical or pharmaceutical treatments for the condition; a wash-out period of at least four weeks after discontinuation of a topical product or 180 days after discontinuation of an oral product for treatment of nail fungus is required Chronic disease, including: diabetes, psoriasis, immune deficiency, severe foot injury, chronic vascular disease or any other condition that would decrease circulation to the extremities at the discretion of the investigator Pregnant or nursing females Investigators, Chesson personnel, or Chesson Scientific Advisory Board members or their immediate family

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIQUICURE<br>Medical Device | Device: LIQUICURE<br>* Topical treatment, 1 time/day, 5 days/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major product-related adverse events for the duration of the feasibility phase. |  | Six months | 
| Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clearance of infection |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toenail, Fungus, Onychomycosis, Dermatophyte