Trials Sponsors Conditions Drugs Pricing

Conditions

Infected Toenails Onychomycosis

Keywords

Toenail FungusPinPointeFootLaserOnychomycosisFungal nails

Outcome Measures

Primary Outcomes (1)

Nail Bed Clearing
Change in amount of clear nail over time.
48 weeks

Secondary Outcomes (1)

Mycology
48 weeks

Study Arms (2)

Randomized great toe

EXPERIMENTAL

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

Device: PinPointe FootLaser

Untreated Toe

NO INTERVENTION

Interventions

PinPointe FootLaserDevice

Medical laser

Randomized great toe

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Volunteers of either sex,
years of age,

Sponsors & Collaborators

PathoLase, Inc.
Industrylead

Study Sites (4)

Rochester Laser Center

Rochester, New York, 14617, United States

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Dermatology Associates

Seattle, Washington, 98101, United States

Mediprobe Research Inc

London, Ontario, N5X 2P1, Canada

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: David M Harris, PhD, Research Director
Organization: PathoLase

Study Officials

David M Harris, PhD
PathoLase, Inc.
STUDY DIRECTOR
Bernard Goffe, MD
Dermatology Associates
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

134 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

June 2009

Date type not reported

This date has not been verified as actual or estimated.

PinPointe FootLaser for the Treatment of Onychomycosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Randomized great toe

Untreated Toe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Randomized great toe

Untreated Toe

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations