Onychomycosis Clinical Trial
Official title:
A Retrospective Evaluation of the Effect of the Erchonia LUNULA™ on the Increase of Clear Nail in Patients With Toenail Onychomycosis
Verified date | October 2015 |
Source | Erchonia Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Great toenail presents with clearly visually identifiable and photographically documentable onychomycosis of the great toenail, or no visible onychomycosis (1 great toenail) - Onychomycosis has been identified as due to 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) - Onychomycosis etiology has been confirmed through positive fungal potassium hydroxide preparation (KOH) testing results Exclusion Criteria: - The category of the presenting visible great toenail onychomycosis (0%-25% onychomycosis involvement; 26%-50% onychomycosis involvement; 51%-75% onychomycosis involvement; 76%-100% onychomycosis involvement) has already met the quota of 5 qualified enrolled great toenails - Spikes of disease extending to nail matrix in the great toenail - Infection involving lunula of the great toenail, e.g. genetic nail disorders, primentary disorders - Great toenail has less than 2mm clear (unaffected) nail plate length beyond the proximal fold - Dermatophytoma or "yellow spike/streak" (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the great toenail - Onychogryphosis - Proximal subungual onychomycosis - White superficial onychomycosis |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Erchonia Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth | Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria. | 6 Months | No |
Secondary | Change in Millimeters (mm) of Clear Nail Bed | Millimeter (mm) of clear nail from the base of the toenail 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 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success. | 6 Months | No |
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