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Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

Primary Purpose

Alopecia Areata

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

308-nm excimer laser to alopecia patch

Liquid light guide tip on laser

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring alopecia areata child, scalp

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Sites / Locations

Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Liquid light guide tip on laser

308-nm excimer laser to alopecia patch

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01736007

First Posted

November 1, 2012

Last Updated

October 29, 2014

Sponsor

Phoenix Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01736007

Brief Title

Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Withdrawn

Why Stopped

was not able to recruit participants

Study Start Date

August 2012 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Phoenix Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata

Keywords

alopecia areata child, scalp

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liquid light guide tip on laser

Arm Type

Sham Comparator

Arm Description

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

Arm Title

308-nm excimer laser to alopecia patch

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

308-nm excimer laser to alopecia patch

Other Intervention Name(s)

PhotoMedex XTRAC XL Excimer Laser System, Model AL 8000

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Liquid light guide tip on laser

Other Intervention Name(s)

Liquid light guide tip applied to Excimer laser

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Time Frame

9 months

Secondary Outcome Measure Information:

Title

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

Description

Measures will include side effects, response to treatment (hair growth), tolerability of therapy, attrition, attendance, and overall satisfaction with this treatment modality.

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harper N Price, MD

Organizational Affiliation

Phoenix Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Judith AJ O'Haver, PhD

Organizational Affiliation

Phoenix Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phoenix Children's Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

12. IPD Sharing Statement

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Childhood Alopecia Areata Study Using the 308-nm Excimer Laser

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