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Completed

NCT Number: NCT00960089

Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Triangle Medical Research Associates, Cary, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIQUICURE

Device

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

Primary outcomes

  1. Freedom from major product-related adverse events for the duration of the feasibility phase.

    Time frame: Six months

  2. Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics

    Time frame: Six months

Secondary outcomes

  1. Time to clearance of infection

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chesson Laboratory Associates, Inc

Industry

Registry information

Official study title

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

Acronym: CT001

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2009
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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