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Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis

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ClinicalTrials.gov Identifier: NCT01920178
Recruitment Status : Terminated (Financial support of the Study withdrawn by Nuvolase, Inc ( PinPointe FootLaser) due to delayed start of the Study and inadequate subjects enrolled)
First Posted : August 9, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Cambridge Health Alliance

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Onychomycosis of Toenails
Intervention Device: PinPointe Foot Laser
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PinPointe Foot Laser Sham Laser Group
Hide Arm/Group Description

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Period Title: Overall Study
Started 5 2
Completed 3 1
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title PinPointe Foot Laser Sham Laser Group Total
Hide Arm/Group Description

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Total of all reporting groups
Overall Number of Baseline Participants 5 2 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 2 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
2
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 2 participants 7 participants
43.2  (13.2) 47.0  (2.8) 44.3  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 2 participants 7 participants
Female
3
  60.0%
1
  50.0%
4
  57.1%
Male
2
  40.0%
1
  50.0%
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 2 participants 7 participants
5 2 7
1.Primary Outcome
Title Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.
Arm/Group Title PinPointe Foot Laser Sham Laser Group
Hide Arm/Group Description:

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.
Arm/Group Title PinPointe Foot Laser Sham Laser Group
Hide Arm/Group Description:

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Number of Participants With Adverse Events During and Following Each Study Treatment
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PinPointe Foot Laser Sham Laser Group
Hide Arm/Group Description:

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Overall Number of Participants Analyzed 5 2
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame 12 months
Adverse Event Reporting Description Adverse events assessed both during and following each study treatment for all 10 toes with 2 laser passes over each clinically infected nail and one laser pass over each nail with no clinical signs of onychomycosis performed at each treatment.
 
Arm/Group Title PinPointe Foot Laser Sham Laser Group
Hide Arm/Group Description

Active laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

Treatment with only localizing (aiming) beam of Pinpointe Foot Laser

PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.

Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser

All-Cause Mortality
PinPointe Foot Laser Sham Laser Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PinPointe Foot Laser Sham Laser Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PinPointe Foot Laser Sham Laser Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/2 (0.00%) 
Withdrawal of financial support by Nuvolase, Inc in June, 2014 with very small enrollment of only 7 subjects ( 40 originally anticipated) led to loss of vital Primary and Secondary Outcome Measures with no reliable or interpretable data produced.
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: Paul M. Heffernan, D.P.M.
Organization: Cambridge Health Alliance
Phone: 617-665-2556
EMail: pheffernan@challiance.org
Layout table for additonal information
Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT01920178     History of Changes
Other Study ID Numbers: 0860/08/11
First Submitted: August 7, 2013
First Posted: August 9, 2013
Results First Submitted: July 15, 2016
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017