Fraxel Laser for Alopecia

NCT03284021 | Withdrawn DMC

• 1 other identifier: STU00205107
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fraxel laser

OTHER

Device: Fractional erbium-glass 1550 nm laser

Interventions

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.

Also known as: Fraxel RE:STORE

Fraxel laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Lasers

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: April 24, 2019
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)