Diode Laser Treatment of Onychomycosis

Onychomycosis Clinical Trial

Official title:

Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452490
• Other study ID #: D4-11-F
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: October 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions

Locations

Country	Name	City	State
United States	Shoreline Foot and Ankle Center	New London	Connecticut
United States	Shoreline Foot and Ankle Center	Westbrook	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ConBio, a Cynosure Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement	Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.	12 months