Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

NCT ID: NCT00960089

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-10-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIQUICURE

Medical Device

Group Type: EXPERIMENTAL

LIQUICURE

Intervention Type: DEVICE

Topical treatment, 1 time/day, 5 days/week

Interventions

LIQUICURE

Topical treatment, 1 time/day, 5 days/week

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chesson Laboratory Associates, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Central Dermatology

Locations

Triangle Medical Research Associates

Cary, North Carolina, United States

Central Dermatology Center

Chapel Hill, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Crescent Medical Research

Salisbury, North Carolina, United States

Countries

United States

Other Identifiers

Chesson Labs CT001-01

Identifier Type: -

Identifier Source: org_study_id