Back to resultsPinPointe FootLaser for the Treatment of Onychomycosis
Primary Purpose
Infected Toenails, Onychomycosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PinPointe FootLaser
Sponsored by
About this trial
This is an interventional treatment trial for Infected Toenails focused on measuring Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails
Eligibility Criteria
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.
Sites / Locations
- Rochester Laser Center
- Endeavor Clinical Trials, PA
- Dermatology Associates
- Mediprobe Research Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Randomized great toe
Untreated Toe
Arm Description
Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Outcomes
Primary Outcome Measures
Nail Bed Clearing
Change in amount of clear nail over time.
Secondary Outcome Measures
Mycology
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00935649
Brief Title
PinPointe FootLaser for the Treatment of Onychomycosis
Official Title
Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PathoLase, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Toenails, Onychomycosis
Keywords
Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Randomized great toe
Arm Type
Experimental
Arm Description
Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Arm Title
Untreated Toe
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
PinPointe FootLaser
Intervention Description
Medical laser
Primary Outcome Measure Information:
Title
Nail Bed Clearing
Description
Change in amount of clear nail over time.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Mycology
Description
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Harris, PhD
Organizational Affiliation
PathoLase, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bernard Goffe, MD
Organizational Affiliation
Dermatology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester Laser Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14617
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Mediprobe Research Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
PinPointe FootLaser for the Treatment of Onychomycosis
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