Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

October 29, 2014 updated by: Phoenix Children's Hospital

Childhood Alopecia Areata Study: Part 1: Feasibility of the 308-nm Excimer Laser in Treatment of Patch Type Alopecia Areata in Pediatric Patients

Alopecia Areata (AA) is a skin restricted autoimmune disease of the hair follicle, resulting in hair loss of the scalp, and in severe cases of the entire body. AA is the second most common cause of alopecia in childhood; no FDA-approved treatments exist. The use of focused narrow-band ultraviolet-B light via the excimer laser is a common treatment for many skin diseases in patients of all ages. In this study, the feasibility of the 308-nm excimer laser for treatment of patch type AA of the scalp will be examined. We anticipate the excimer laser will be safe and a feasible option for patients with patch type AA. The excimer laser may represent a novel treatment for childhood AA and no comparison or large studies currently exist in the literature.

Hypotheses The 308-nm excimer laser procedure is a feasible, well-tolerated and safe treatment for patch type alopecia areata of the scalp in children.

Study Overview

Detailed Description

The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children (age 6-17 years) diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration. Patients meeting the inclusion criteria will be randomly enrolled in a treatment group or placebo group. Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs.

Specific Aims Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks. Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children 6-17 years old, diagnosed with patch type alopecia areata for a minimum of 6 months prior to enrollment involving the scalp.
  2. A Parent/guardian consent and child assent (in those 8 years old or greater) must be obtained.
  3. Parent/guardian and patient agree to MED dose test with a 24 hour follow up visit and a 12 week period of twice weekly treatment in either group, as well as baseline, interim and end of study visits.
  4. Parent/guardian and child must be able to understand English or Spanish to participate.
  5. Parent/guardian must agree to have the patient undergo a washout period of 6 weeks prior to the enrollment of the study if the patient is currently on treatment of any kind (oral and/or topical) for AA.

Exclusion Criteria:

  1. Children who have been diagnosed with an autoimmune skin disease or photosensitivity disorder.
  2. Children who have been using topical steroids to the scalp, have other scalp disease or are using injected or oral steroids, biologic agents or chemotherapy for other medical conditions.
  3. Children under current treatment for other skin conditions with oral medications (such as an oral corticosteroid) and/or topical treatments such as topical corticosteroids that may affect hair regrowth. Specifically, for topical medications, any child that requires the use of class 1-2 topical corticosteroids will be excluded.

3. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.

4. Patients with alopecia universalis, totalis, ophiasis pattern or diffuse AA may not participate in this feasibility study.

4. Parent/guardian who do not consent or children who do not assent to participate.

5. Any subject who has had AA for less than 6 months and is not willing to undergo a 6 week wash-out period prior to start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Liquid light guide tip on laser
Excimer laser treatment with 308-nm excimer laser with guide tip applied to alopecia patch twice a week.
Sham treatment involves placement of liquid light guide tip developed by the laser company which attaches to the end of the hand wand and blocks the laser light from passing to the target. Patients are treated twice a week for 12 weeks.
Other Names:
  • Liquid light guide tip applied to Excimer laser
Active Comparator: 308-nm excimer laser to alopecia patch
Laser treatment with 308-nm excimer laser procedure to alopecia patch twice a week with increasing fluence as tolerated.
MED dosing as per protocol with beginning at 50 mJ/cm2 below MED with increases by 50mJ/cm2 every 2 treatments as tolerated. Maximum dosing would be 850mJ.Treatments given twice a week for 12 weeks.
Other Names:
  • PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The goal of this study is to assess the feasibility, safety and response to treatment of the use of the 308-nm excimer laser in children diagnosed with patch type alopecia areata involving the scalp, present for more than 6 months duration
Time Frame: 9 months
Response to treatment during and after the 12-week laser treatment course will be measured in terms of hair regrowth utilizing the SALT score and 2 blinded evaluations of subject photographs. Follow up post treatment at 36 weeks and 48 weeks.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks
Time Frame: 48 weeks
Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Harper N Price, MD, Phoenix Children's Hospital
  • Principal Investigator: Judith AJ O'Haver, PhD, Phoenix Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PCH-derm001
  • IDE Number: G110232/S2 (Other Identifier: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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