A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis

Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable

The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No

• Previous treatment with at least 90 days of oral Terbinafine and completed the treatment at least 1 year ago

• Able to feel a Semmes-Weinstein monofilament at the tip of each toe

• Must have at least 50% involvement in at least one great toenail

• Must be willing and able to present for one treatment visit and two follow-up visits at 6 months and 12 months following initial treatment to photograph the nails

• Must be willing to apply topical antifungal to the skin surrounding the toes on a daily basis and be willing to spray shoes with an aerosolized antifungal on a weekly basis

• Must have dystrophic toenails which clinically appear to be mycotic

• Age ≥ 18 years and ≤ 70 years

• Willing to comply with study requirements, including regular nail debridement as indicated by the investigator

• Willing to provide informed consent to participate

United States
Cambridge Health Alliance
Time Frame
Start Date: April 2013
Completion Date: May 2015
Target number of participants: 7
Active Comparator: PinPointe Foot Laser
Active laser
Sham Comparator: Sham laser group
Treatment with only localizing (aiming) beam of Pinpointe Foot Laser
Related Therapeutic Areas
Leads: Cambridge Health Alliance

This content was sourced from clinicaltrials.gov

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