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Fraxel Laser for Alopecia

Primary Purpose

Alopecia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional erbium-glass 1550 nm laser
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Males and females ≥ 18 years old
  2. Subjects are in good health as judged by the investigator.
  3. Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
  4. Subject is seeking treatment for alopecia.
  5. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
  6. 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:

  1. Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
  2. 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.
  3. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
  4. History of recurrent facial or labial herpes simplex infection
  5. History of hypertrophic scars or keloids
  6. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
  7. Pregnant or breast feeding
  8. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
  9. Subjects who are unable to understand the protocol or give informed consent.

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fraxel laser

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2017
Last Updated
December 2, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03284021
Brief Title
Fraxel Laser for Alopecia
Official Title
A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study did not start.
Study Start Date
April 24, 2019 (Anticipated)
Primary Completion Date
April 24, 2019 (Anticipated)
Study Completion Date
April 24, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fraxel laser
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Fractional erbium-glass 1550 nm laser
Other Intervention Name(s)
Fraxel RE:STORE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical change of alopecia from baseline to 150 days.
Description
Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.
Time Frame
Baseline and 150 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fraxel Laser for Alopecia

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