Evaluation of the Erchonia Lunula Laser for Treatment of Onychomycosis
Research type
Research Study
Full title
An Evaluation of the Effect of the Erchonia Lunula Laser for the Treatment of Toenail Onychomycosis
IRAS ID
277609
Contact name
Travis Sammons
Contact email
Sponsor organisation
Erchonia Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, manufactured by Erchonia Corporation (the Sponsor) for the treatment of onychomycosis of the toenail.
The Erchonia LunulaLaser has previously been issued FDA 510(k) clearance under K153164: “The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)”
The treatment is administered using a non-thermal laser with no expected side effects. The treatment administration phase of the study will last 11 months, comprised of four initial weekly treatment administration phase followed by an every two-month maintenance treatment administration phase. The endpoint measures will be two months post final treatment, and include; measurement of mm of clear nail, percentage of clinical onychomycosis involvement determination, and mycological evaluation. Study Sites involved will include Podiatrists and Dermatologists.
Presently, there is no perfect cure for toenail fungus. Even the most effective oral medications are successful only about half the time. Topical medications are successful less than 10% of the time. As 10% of the adult population is affected by toenail onychomycosis, the need for a more effective and lasting cure is evident.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0119
Date of REC Opinion
11 Jun 2020
REC opinion
Further Information Favourable Opinion