Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

Onychomycosis Clinical Trial

— CT001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960089
• Other study ID #: Chesson Labs CT001-01
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: January 26, 2016
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: January 2016
• Source: Chesson Laboratory Associates, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• LIQUICURE
Topical treatment, 1 time/day, 5 days/week

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Chesson Laboratory Associates, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major product-related adverse events for the duration of the feasibility phase.		Six months	No
Primary	Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics		Six months	No
Secondary	Time to clearance of infection		6 months	No