Phase 3 N=139 Randomized Single-blind Treatment

PinPointe FootLaser for the Treatment of Onychomycosis

Infected Toenails · Onychomycosis

Bottom Line

View on ClinicalTrials.gov: NCT00935649 ↗

Enrolled (actual)

139

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Nail Bed Clearing

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: PinPointe FootLaser (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: PathoLase, Inc.
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Nail Bed Clearing	—	—
SECONDARY Mycology	—	—

Summary

To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00935649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.