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

Evaluation of the Efficacy of Chesson Labs LIQUICURE™ for Treatment of Onychomycosis

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Device: LIQUICURE

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Triangle Medical Research Associates
    • Chapel Hill, North Carolina, United States, 27517
      • Central Dermatology Center
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIQUICURE; Medical Device	Device: LIQUICURE; Topical treatment, 1 time/day, 5 days/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Time to clearance of infection	6 months

Collaborators and Investigators

• Sponsor: Chesson Laboratory Associates, Inc
• Investigators: Principal Investigator: Beth Goldstein, MD, Central Dermatology

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 14, 2009
• First Submitted That Met QC Criteria: August 14, 2009
• First Posted (Estimate): August 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Onychomycosis; Fungus; Dermatophyte; Toenail
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: Chesson Labs CT001-01