PinPointe FootLaser for the Treatment of Onychomycosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-11-30

Brief Summary

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

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Detailed Description

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The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.

Conditions

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Infected Toenails Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Randomized great toe

Subjects with both great toes infected. Right/left randomized to treatment / no treatment

Group Type EXPERIMENTAL

PinPointe FootLaser

Intervention Type DEVICE

Medical laser

Untreated Toe

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PinPointe FootLaser

Medical laser

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No