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Fraxel Laser for Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284021
Recruitment Status : Withdrawn (The study did not start.)
First Posted : September 15, 2017
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Alopecia Device: Fractional erbium-glass 1550 nm laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
Estimated Study Start Date : April 24, 2019
Estimated Primary Completion Date : April 24, 2019
Estimated Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Erbium

Arm Intervention/treatment
Fraxel laser Device: Fractional erbium-glass 1550 nm laser
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.
Other Name: Fraxel RE:STORE




Primary Outcome Measures :
  1. Clinical change of alopecia from baseline to 150 days. [ Time Frame: Baseline and 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284021


Locations
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United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University
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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT03284021    
Other Study ID Numbers: STU00205107
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical