Childhood Alopecia Areata Study Using the 308-nm Excimer Laser



Status:Completed
Conditions:Dermatology, Hair Loss
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 17
Updated:11/8/2014
Start Date:August 2012
End Date:August 2014
Contact:Judith AJ O'Haver, PhD
Email:johaver@phoenixchildrens.com
Phone:602-933-0895

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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.

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.

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.
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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