Fraxel Laser for Alopecia | NCT03284021

Studies
Fraxel Laser for Alopecia

NCT03284021

Sponsor

Northwestern University

Status

Withdrawn

Last Update Posted

Dec 6, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Alopecia

Interventions

Fractional erbium-glass 1550 nm laser

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

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study did not start.

Expanded Access Info

Start Date

Apr 24, 2019Estimated

Primary Completion Date

Apr 24, 2019Estimated

Completion Date

Apr 24, 2019Estimated

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 13, 2017

First Posted Date

Sep 15, 2017Actual

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

Dec 2, 2021

Last Update Posted Date

Dec 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.

This study was a pilot study designed to determine feasibility of this procedure.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fraxel laser	Other		Device: Fractional erbium-glass 1550 nm laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fractional erbium-glass 1550 nm laser	Device	The fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical change of alopecia from baseline to 150 days.	Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.	Baseline and 150 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females ≥ 18 years old
Subjects are in good health as judged by the investigator.
Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
Subject is seeking treatment for alopecia.
Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
History of recurrent facial or labial herpes simplex infection
History of hypertrophic scars or keloids
Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
Pregnant or breast feeding
Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Subjects who are unable to understand the protocol or give informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies