Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

NCT01736007 | Withdrawn

• 2 other identifiers: PCH-derm001IDE Number: G110232/S2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

alopecia areata child; scalp

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  9 months

Secondary Outcomes (1)

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

  48 weeks

Study Arms (2)

Liquid light guide tip on laser

SHAM COMPARATOR

Excimer laser treatment with 308-nm excimer laser with guide tip applied to alopecia patch twice a week.

Device: Liquid light guide tip on laser

308-nm excimer laser to alopecia patch

ACTIVE COMPARATOR

Laser treatment with 308-nm excimer laser procedure to alopecia patch twice a week with increasing fluence as tolerated.

Device: 308-nm excimer laser to alopecia patch

Interventions

308-nm excimer laser to alopecia patch DEVICE

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.

Also known as: PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000

308-nm excimer laser to alopecia patch

Liquid light guide tip on laser DEVICE

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.

Also known as: Liquid light guide tip applied to Excimer laser

Liquid light guide tip on laser

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-17 years old, diagnosed with patch type alopecia areata for a minimum of 6 months prior to enrollment involving the scalp.
• A Parent/guardian consent and child assent (in those 8 years old or greater) must be obtained.
• 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.
• Parent/guardian and child must be able to understand English or Spanish to participate.
• 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.

You may not qualify if:

• Children who have been diagnosed with an autoimmune skin disease or photosensitivity disorder.
• 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.
• 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.
• \. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.
• \. Patients with alopecia universalis, totalis, ophiasis pattern or diffuse AA may not participate in this feasibility study.
• \. Parent/guardian who do not consent or children who do not assent to participate.
• \. 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.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Harper N Price, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

• Judith AJ O'Haver, PhD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 28, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2014
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

US (1)