Trial Outcomes & Findings for PinPointe FootLaser for the Treatment of Onychomycosis (NCT NCT00935649)

Results Overview

Change in amount of clear nail over time.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

134 participants

Primary outcome timeframe

48 weeks

Results posted on

2013-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized Great Toe Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Overall Study STARTED	139
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PinPointe FootLaser for the Treatment of Onychomycosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Great Toe n=139 Participants Subjects with both great toes infected. Right/left randomized to treatment / no treatment
Age Continuous	52.1 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: 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.

Change in amount of clear nail over time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Population: 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.

KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.

Outcome measures

Outcome data not reported

Adverse Events

Treated Great Toe

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Untreated Great Toe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated Great Toe n=139 participants at risk Laser treatment of great toe	Untreated Great Toe untreated control great toe
Surgical and medical procedures intraoperative foot pain	10.8% 15/139 • 48 weeks Adverse events not assessed for untreated toe. Adverse events are per toe not per patient.	— 0/0 • 48 weeks Adverse events not assessed for untreated toe. Adverse events are per toe not per patient.

Additional Information

David M Harris, PhD, Research Director

PathoLase

Phone: 510-502-3345

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place