PinPointe FootLaser for the Treatment of Onychomycosis

Onychomycosis Clinical Trial

Official title:

Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935649
• Other study ID #: CLN0001.p.A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2009
• Last updated: April 8, 2013
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: PathoLase, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

Description:

The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Volunteers of either sex,

• 18-80 years of age,

• Both great toes with clinical signs of infection.

• Positive KOH or culture test

Exclusion Criteria:

• Existing or history of cancer/skin malignancy,

• Use of oral antifungal agents in past 6 months,

• Use of topical antifungal agents in past 1 month,

• Loss of protective sensation in either foot,

• Infection involving lunula of either great toe,

• Longitudinal streaks/spikes of either great toenail,

• Distal nail thickness > 2 mm of either great toe,

• Prior surgical treatment of either great toe in past 12 months,

• Participation in another medical device/pharmaceutical study,

• Condition that investigator determines makes it unsafe for subject to participate,

• Pregnancy, breastfeeding or plans to become pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infected Toenails
• Onychomycosis

Intervention

Device:
• PinPointe FootLaser
Medical laser

Locations

Country	Name	City	State
Canada	Mediprobe Research Inc	London	Ontario
United States	Rochester Laser Center	Rochester	New York
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Dermatology Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
PathoLase, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nail Bed Clearing	Change in amount of clear nail over time.	48 weeks	No
Secondary	Mycology	KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.	48 weeks	No