NCT01736007

Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-06-01
• Completion: 2014-08-01
• First posted: 2012-11-28
• Last updated: 2014-10-31

Locations

1 site across 1 country: United States