Clinical Trial: Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Phoenix Children's Hospital

Current 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 [ 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Phoenix Children's Hospital

Dates:
Date Received: November 1, 2012
Date Started: August 2012
Date Completion: August 2014
Last Updated: October 29, 2014
Last Verified: October 2014