Trial Outcomes & Findings for Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis (NCT NCT01920178)

NCT ID: NCT01920178

Last Updated: 2017-05-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	PinPointe Foot Laser 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	Sham Laser Group 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 Study STARTED	5	2
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	PinPointe Foot Laser 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	Sham Laser Group 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 Study Lost to Follow-up	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PinPointe Foot Laser n=5 Participants 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	Sham Laser Group n=2 Participants 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 n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	47.0 years STANDARD_DEVIATION 2.8 • n=7 Participants	44.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	PinPointe Foot Laser n=5 Participants 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	Sham Laser Group n=2 Participants 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
Number of Participants With Adverse Events During and Following Each Study Treatment	0 participants	0 participants

Adverse Events

PinPointe Foot Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Laser Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul M. Heffernan, D.P.M.

Cambridge Health Alliance

Phone: 617-665-2556

Email: pheffernan@challiance.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place