Alopecia Areata Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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