Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

NCT00960089 | Completed DMC

• 1 other identifier: Chesson Labs CT001-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

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

Keywords

Toenail; Fungus; Onychomycosis; Dermatophyte

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time to clearance of infection

  6 months

Study Arms (1)

LIQUICURE

EXPERIMENTAL

Medical Device

Device: LIQUICURE

Interventions

LIQUICURE DEVICE

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

LIQUICURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chesson Laboratory Associates, Inc: lead

Study Sites (4)

Triangle Medical Research Associates

Cary, North Carolina, 27518, United States

Location

Central Dermatology Center

Chapel Hill, North Carolina, 27517, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Crescent Medical Research

Salisbury, North Carolina, 28144, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Beth Goldstein, MD

  Central Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: July 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

US (4)