Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Phoenix Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01736007
First received: November 1, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Alopecia Areata
Device: 308-nm excimer laser to alopecia patch
Device: Liquid light guide tip on laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Childhood Alopecia Areata Study: Part 1: Feasibility of the 308-nm Excimer Laser in Treatment of Patch Type Alopecia Areata in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


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


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Liquid light guide tip on laser
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 Name: 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.
Device: 308-nm excimer laser to alopecia patch
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 Name: PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736007

Contacts
Contact: Judith AJ O'Haver, PhD 602-933-0895 johaver@phoenixchildrens.com
Contact: Harper N Price, MD 602-933-0895 hprice@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Harper N Price, MD    602-933-0895    hprice@phoenixchildrens.com   
Contact: Judith AJ OHaver, PhD    602-933-0895    johaver@phoenixchildrens.com   
Principal Investigator: Harper N Price, MD         
Principal Investigator: Judith AJ OHaver, PhD         
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Harper N Price, MD Phoenix Children's Hospital
Principal Investigator: Judith AJ O'Haver, PhD Phoenix Children's Hospital
  More Information

No publications provided

Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01736007     History of Changes
Other Study ID Numbers: PCH-derm001, IDE Number: G110232/S2
Study First Received: November 1, 2012
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:
alopecia areata child
scalp

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 16, 2014