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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02242019 |
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Date of registration:
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12/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus
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Scientific title:
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An Evaluation of the Effect of the Erchonia LUNULA on Treating Toenail Onychomycosis |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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109 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02242019 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Robert Sullivan, Podiatry |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Onychomycosis present in at least one great toenail, identified as current
bacterial/fungal infection classified by the investigator as onychomycosis, with the
nail presenting positive on visual inspection for somewhat thickened nail plate with a
cloudy appearance and some discoloration (white to yellow to brown).
- 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 in the affected great toenail(s).
- Infection involving lunula of the affected toenail(s), e.g., genetic nail disorders,
primentary disorders.
- Affected great toenail(s) has less than 2mm clear (unaffected) nail plate length
beyond the proximal fold.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic
keratin between the nail plate and nail bed) on the affected great toenail(s).
- 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 affected great toenail(s) is present: proximal
subungual onychomycosis; white superficial onychomycosis; dermatophytoma or "yellow
spike/streak"; exclusively lateral disease
- Confounding problems/abnormalities of the great toenail(s).
- Any abnormality of the affected great toenail(s) that could prevent a normal appearing
nail if clearing of infection is achieved.
- Inability for the affected great toenail(s) 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).
- Subject is unwilling or unable to refrain from employing other (non-study) treatments
(traditional and alternative) for his or her toenail onychomycosis throughout study
participation.
- Subject is unwilling or unable to refrain from the use of nail cosmetics such as clear
and/or colored nail lacquers until the end of study participation.
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Onychomycosis
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Intervention(s)
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Device: Erchonia LUNULA
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Primary Outcome(s)
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Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth
[Time Frame: Baseline and 36 Weeks]
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Change in Millimeters (mm) of Clear Nail Bed
[Time Frame: Baseline and 36 Weeks]
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Secondary Outcome(s)
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Change in Percent (%) of Onychomycosis Disease Involvement
[Time Frame: Baseline and 36 Weeks]
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Secondary ID(s)
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EC_TFRS_004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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