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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chesson Laboratory Associates, Inc
ClinicalTrials.gov Identifier:
NCT00960089
First received: August 14, 2009
Last updated: January 26, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention
Onychomycosis
Device: LIQUICURE

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Chesson Labs LIQUICURE™ for Treatment of Onychomycosis

Resource links provided by NLM:


Further study details as provided by Chesson Laboratory Associates, Inc:

Primary Outcome Measures:
  • Freedom from major product-related adverse events for the duration of the feasibility phase. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to clearance of infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIQUICURE
Medical Device
Device: LIQUICURE
Topical treatment, 1 time/day, 5 days/week

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960089

Locations
United States, North Carolina
Triangle Medical Research Associates
Cary, North Carolina, United States, 27518
Central Dermatology Center
Chapel Hill, North Carolina, United States, 27517
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
Sponsors and Collaborators
Chesson Laboratory Associates, Inc
Investigators
Principal Investigator: Beth Goldstein, MD Central Dermatology
  More Information

Responsible Party: Chesson Laboratory Associates, Inc
ClinicalTrials.gov Identifier: NCT00960089     History of Changes
Other Study ID Numbers: Chesson Labs CT001-01 
Study First Received: August 14, 2009
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Chesson Laboratory Associates, Inc:
Toenail
Fungus
Onychomycosis
Dermatophyte

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 21, 2016