Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

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Brief Title

Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

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

Brief Summary

      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.
    

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


Primary Outcome

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

Secondary Outcome

 Evaluate the feasibility and safety of twice-weekly excimer laser treatments over a period of 12 weeks

Condition

Alopecia Areata

Intervention

308-nm excimer laser to alopecia patch

Study Arms / Comparison Groups

 Liquid light guide tip on laser
Description:  Excimer laser treatment with 308-nm excimer laser with guide tip applied to alopecia patch twice a week.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

August 2012

Completion Date

August 2014

Primary Completion Date

June 2013

Eligibility 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.
      

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Harper N Price, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01736007

Organization ID

PCH-derm001

Secondary IDs

IDE Number: G110232/S2

Responsible Party

Sponsor

Study Sponsor

Phoenix Children's Hospital


Study Sponsor

Harper N Price, MD, Principal Investigator, Phoenix Children's Hospital


Verification Date

October 2014