Phase 3
Completed N=139
PinPointe FootLaser for the Treatment of Onychomycosis
Infected Toenails · Onychomycosis
Source: ClinicalTrials.gov NCT00935649 ↗
Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Nail Bed Clearing
Summary
To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nail Bed Clearing |
— | — |
| SECONDARY Mycology |
— | — |
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.
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. Informational only — not medical advice.