Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus (CT001)

Chesson Laboratory Associates

Status

Completed

Conditions

Onychomycosis

Treatments

Device: LIQUICURE

Study type

Interventional

Funder types

Industry

Identifiers

NCT00960089

Chesson Labs CT001-01

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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