Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

Launched by CHESSON LABORATORY ASSOCIATES, INC · Aug 14, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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