Clinical trial NCT01452490: Diode Laser Treatment of Onychomycosis
Official title: Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Keywords: Onychomycosis
Toenail Fungus
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.


Eligibility criteria: Inclusion Criteria:

* Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
* Fitzpatrick Skin Type I-IV
* Written and verbal informed consent
* Able to comply with study instructions and to return to the clinic for required visits
* Agrees to refrain from other active topical, laser or light-based treatment to the great toes
* Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis

Exclusion Criteria:

* Pregnancy, breastfeeding or planning to become pregnant
* History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
* Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
* Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
* Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
* Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
* Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
* Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
* Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
* Immunocompromised status, or with existing (or history of) cancer/skin malignancy
* Distal nail thickness of greater than 2mm in the affected great toenail

Primary outcomes:
measure: Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New London
country: United States
facility: Shoreline Foot and Ankle Center
state: Connecticut
city: Westbrook
country: United States
facility: Shoreline Foot and Ankle Center
state: Connecticut
Study officials:
affiliation: Shoreline Foot and Ankle Center
name: Darren Courtright, DPM
role: PRINCIPAL_INVESTIGATOR
References: