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Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus (CT001)

Primary Purpose

Onychomycosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LIQUICURE

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Toenail, Fungus, Onychomycosis, Dermatophyte

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Triangle Medical Research Associates
Central Dermatology Center
Wake Research Associates
Crescent Medical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LIQUICURE

Arm Description

Medical Device

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Time to clearance of infection

Full Information

NCT ID

NCT00960089

First Posted

August 14, 2009

Last Updated

January 26, 2016

Sponsor

Chesson Laboratory Associates, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00960089

Brief Title

Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

Acronym

CT001

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chesson Laboratory Associates, Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onychomycosis

Keywords

Toenail, Fungus, Onychomycosis, Dermatophyte

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIQUICURE

Arm Type

Experimental

Arm Description

Medical Device

Intervention Type

Device

Intervention Name(s)

LIQUICURE

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Six months

Title

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

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Time to clearance of infection

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beth Goldstein, MD

Organizational Affiliation

Central Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Triangle Medical Research Associates

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Central Dermatology Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Facility Name

Wake Research Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Crescent Medical Research

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

12. IPD Sharing Statement

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Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

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