Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the
Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Skin Lesions
Enrollment Eligibility
Inclusion Criteria:
- Visual clinical presentation of onychomycosis in the target great toenail is distal
subungual onychomycosis (DSO), visualized as a nail with normal surface texture and
thickness but variable "bays" of white nail that extend from the distal nail tip
proximally into the area of the nail bed
- Clinical involvement of onychomycosis in the target toenail is up to 60%
- Confirmation of the presence of fungal infection through a positive KOH stain finding
and a positive fungal culture finding
- Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum)
or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection.
In the event of the KOH stain and the fungal culture provide conflicting results,
i.e., one is positive and the other negative, resolution may be obtained by a second
negative fungal culture finding from a nail clipping from the same nail
- 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:
- Visual clinical presentations of onychomycosis in the target great toenail that are
inconsistent with the clinical presentation of distal subungual onychomycosis (DSO),
in whole or in part (i.e. indicative of mixed etiology); specifically proximal
subungual onychomycosis (PSO); superficial white onychomycosis (SWO); complete
dystrophy; other nail changes.
- Identification through fungal culture of the growth of a rare fungal species (i.e. not
Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed
dermatophyte/Candida infection) or non-fungal organisms such as mold or bacteria
- 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)
- Infection involving lunula e.g., genetic nail disorders, primentary disorders
- Severe plantar (moccasin) tinea pedis
- Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known
to induce nail changes
- Onychogryphosis
- Trauma from ill-fitting shoes, running, or overly-aggressive nail care
- Previous toenail surgery
- Uncontrolled diabetes mellitus
- Peripheral vascular disease
- Recurrent cellulitis
- Lymphatic insufficiency
- Immune compromise (whether due to underlying medical disorders or immuno-suppressive
treatments)
- Other compromised states of health
- Known photosensitivity disorder
- Use of oral antifungal drugs in the prior 6 months
- Use of topical treatment of the skin or nails within the prior 2 months
- Any abnormality of the toenail that could prevent a normal appearing nail from
occurring if clearing of infection is achieved.
- Current trauma, open wound on or about the treatment area
- Deformity of the target toe/toenail secondary to fungal infection/onychomycosis due to
prior injury, surgical procedures or another medical condition
- Pregnant 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.