Status:
COMPLETED
Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus
Lead Sponsor:
Chesson Laboratory Associates, Inc
Conditions:
Onychomycosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00960089
Start Date
July 1 2008
End Date
October 1 2010
Last Update
January 27 2016
Active Locations (4)
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1
Triangle Medical Research Associates
Cary, North Carolina, United States, 27518
2
Central Dermatology Center
Chapel Hill, North Carolina, United States, 27517
3
Wake Research Associates
Raleigh, North Carolina, United States, 27612
4
Crescent Medical Research
Salisbury, North Carolina, United States, 28144