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Fraxel Laser for Alopecia

NCT ID: NCT03284021

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2019-04-24

Brief Summary

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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

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Conditions

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Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fraxel laser

Group Type OTHER

Fractional erbium-glass 1550 nm laser

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Fraxel RE:STORE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00205107

Identifier Type: -

Identifier Source: org_study_id