Using Light Therapy to Treat Toe Nail Fungus | NCT00771732

Studies
Using Light Therapy to Treat Toe Nail Fungus

NCT00771732

Sponsor

Nomir Medical Technologies

Status

Unknown status

Last Update Posted

Oct 13, 2008Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Onychomycosis

Interventions

light therapy
light therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07-301

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Aug 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jul 7, 2008

First Submission Date that Met QC Criteria

Oct 10, 2008

First Posted Date

Oct 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To see if four sessions of light therapy successfully treats nail fungus.

Detailed Description

This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Light therapy	Device: light therapy
2	Sham Comparator	6 minute "session" given with machine "off"	Device: light therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light therapy	Device	6 minute light therapy	1	laser threapy

Measure	Description	Time Frame
clinical improvement		six months

Measure	Description	Time Frame
mycological negative		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

toe nail fungus, not infolving lunula
between ages 18-70 years old

Exclusion Criteria:

not on systemic anti-fungal medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mary E Oster	Contact	781-893-1000		m.oster@nomirmedical.com
Alan Robbins, M.D.	Contact	781-893-1000		alanhrobbins@comcast.com

Overall Officials

Name	Affiliation	Role
Alan Robbins, M.D.	Nomir Medical Technologies	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paula Angelini, DPM	Recruiting	Southborough	Massachusetts	02452	United States

Condition Browse Module

MeSH Terms

ID	Term
D014009	Onychomycosis

Ancestor Terms

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided