- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534689
Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus
An Evaluation of the Effect of the Erchonia FX-405™ on Treating Toenail Onychomycosis Clinical Study
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Mesa, Arizona, United States, 85204
- Arizona Institute of Footcare Physicians
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Onychomycosis present in at least one great toenail.
- Disease involvement is at least 25%.
- Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.
Exclusion Criteria:
- Spikes of disease extending to nail matrix.
- Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
- Less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed).
- Chronic plantar (moccasin) tinea pedis.
- History of current or past psoriasis of the skin and/or nails.
- Concurrent lichen planus.
- Onychogryphosis.
- Any of the following conditions of the great toenail:
- proximal subungual onychomycosis
- white superficial onychomycosis
- dermatophytoma or "yellow spike/streak"
- exclusively lateral disease
- confounding problems/abnormalities of the great toenail(s).
- Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved.
- Inability for the toenail to become normal in the opinion of the investigator.
- History of multiple repeated failures with previous therapies for onychomycosis.
- Trauma to the affected great toenail(s).
- Use of oral antifungal agents in the past 6 months.
- Use of topical antifungal agents in the past 1 month.
- Prior surgical treatment of the affected great toe(s).
- Cancer and/or treatment of any type of cancer within the last six months.
- Peripheral vascular disease or peripheral circulatory impairment.
- History of uncontrolled diabetes mellitus.
- Known immunodeficiency.
- Known sensitivity, or contraindication, to light therapy.
- Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
- Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study.
- Participation in a clinical study or other type of research in the past 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erchonia FX-405™ Laser
The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light.
The the power reaching the surface of the skin is 1 mW
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The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail.
The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Time Frame: 12 weeks
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Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria. |
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Millimeter (mm) of Clear Nail Bed
Time Frame: 12 weeks
|
Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program.
Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration.
An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success.
A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.
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12 weeks
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Change in Percent (%) of mm Clear Nail
Time Frame: 12 weeks
|
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program.
Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration.
The percent (%) of increase in clear nail from baseline was calculated from there.
|
12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kerry Zang, DPM
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC_TF_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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