Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:July 2008
End Date:October 2010

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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.


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
We found this trial at
4
sites
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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410 Mocksville Avenue
Salisbury, North Carolina 28144
704-647-9913
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Cary, North Carolina 27518
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Cary, NC
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Chapel Hill, North Carolina 27517
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Chapel Hill, NC
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