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Fraxel Laser for Alopecia

Sponsor
Northwestern University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03284021
Collaborator
(none)
0
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fractional erbium-glass 1550 nm laser
 N/A

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
Apr 24, 2019
Anticipated Primary Completion Date :
Apr 24, 2019
Anticipated Study Completion Date :
Apr 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Fraxel RE:STORE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical change of alopecia from baseline to 150 days. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Department of Dermatology Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Murad Alam, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Sep 15, 2017
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata

    Study Results

    No Results Posted as of Dec 6, 2021