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PinPointe FootLaser for the Treatment of Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935649
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Information provided by:
PathoLase, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Infected Toenails
Onychomycosis
Intervention Device: PinPointe FootLaser
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Randomized Great Toe
Hide Arm/Group Description Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Period Title: Overall Study
Started 139
Completed 134
Not Completed 5
Arm/Group Title Randomized Great Toe
Hide Arm/Group Description Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Overall Number of Baseline Participants 139
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants
52.1  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
Female
38
  27.3%
Male
101
  72.7%
1.Primary Outcome
Title Nail Bed Clearing
Hide Description Change in amount of clear nail over time.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.
Arm/Group Title Treated Great Toe Untreated Great Toe
Hide Arm/Group Description:
Laser treatment of great toe
untreated control great toe
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Mycology
Hide Description KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.
Arm/Group Title Treated Great Toe Untreated Great Toe
Hide Arm/Group Description:
Laser treatment of great toe
untreated control great toe
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 48 weeks
Adverse Event Reporting Description Adverse events not assessed for untreated toe. Adverse events are per toe not per patient.
 
Arm/Group Title Treated Great Toe Untreated Great Toe
Hide Arm/Group Description Laser treatment of great toe untreated control great toe
All-Cause Mortality
Treated Great Toe Untreated Great Toe
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treated Great Toe Untreated Great Toe
Affected / at Risk (%) Affected / at Risk (%)
Total   0/139 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated Great Toe Untreated Great Toe
Affected / at Risk (%) Affected / at Risk (%)
Total   15/139 (10.79%)   0/0 
Surgical and medical procedures     
intraoperative foot pain  15/139 (10.79%)  0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David M Harris, PhD, Research Director
Organization: PathoLase
Phone: 510-502-3345
EMail: bmcinc@comcast.net
Layout table for additonal information
Responsible Party: David M Harris, PhD, PathoLase, Inc
ClinicalTrials.gov Identifier: NCT00935649    
Other Study ID Numbers: CLN0001.p.A
First Submitted: July 7, 2009
First Posted: July 9, 2009
Results First Submitted: April 8, 2013
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013