OnychomycosisCT001NCT00960089
Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus
A study testing LIQUICURE in people with Onychomycosis, run by Chesson Laboratory Associates, Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- LIQUICURE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Triangle Medical Research Associates
Cary, North Carolina, 27518
Central Dermatology Center
Chapel Hill, North Carolina, 27517
Wake Research Associates
Raleigh, North Carolina, 27612
Crescent Medical Research
Salisbury, North Carolina, 28144
About this study
Official title: 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.
- Conditions
- Onychomycosis
- Being tested
- LIQUICURE
- Keywords
- Toenail, Fungus, Onychomycosis, Dermatophyte
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIQUICUREDevice
Topical treatment, 1 time/day, 5 days/week
| Study group | Role | What they receive |
|---|---|---|
| LIQUICURE | Experimental | Medical Device Receives: Device: LIQUICURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major product-related adverse events for the duration of the feasibility phase.
Measured: Six months
Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics
Measured: Six months
Secondary outcomes (1)
Time to clearance of infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chesson Laboratory Associates, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Goldstein, MD, Principal investigator, Central Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960089
- Sponsor's protocol ID
- Chesson Labs CT001-01
- Acronym
- CT001
- Status last verified
- Jan 2016
- First submitted
- 14 Aug 2009
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Chesson Labs LIQUICURE™ for Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT00960089
- Acronym / sponsor ID
- CT001 / Chesson Labs CT001-01
- Conditions
- Onychomycosis
- Keywords
- Toenail, Fungus, Onychomycosis, Dermatophyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Chesson Laboratory Associates, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIQUICURE | Experimental | Device: LIQUICUREMedical Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIQUICURETopical treatment, 1 time/day, 5 days/week | Device | LIQUICURE |
Primary outcome
Freedom from major product-related adverse events for the duration of the feasibility phase.
Time frame: Six months
Clearance of fungal nail infection defined by negative culture and improvement in visual nail characteristics
Time frame: Six months
1 secondary outcome
Time to clearance of infection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Goldstein, MD principal investigator
Central Dermatology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIQUICURE in people with Onychomycosis, run by Chesson Laboratory Associates, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major product-related adverse events for the duration of the feasibility phase. (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.