This is an interventional pilot study assessing the tolerability of needle-free delivery administration of ILTA with the Med-Jet as an alternative to conventional syringe and needle in patients with patchy pediatric alopecia areata. There will be a total of four (4) or five (5) visits necessary for study participation. The investigators hypothesize that the Med-Jet will have acceptable pain tolerability, efficacy, safety, and a positive impact on patient quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.
For the pain score assessment, patients will rate their pain from the needle-free injection using the Wong-Baker FACES Scale and a numerical rating scale, in which score ranges from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Time frame: 12 weeks
Change in Patient Reported Hair Loss
The patient-reported efficacy assessments will consist of the Patient-Reported Hair Loss and the 5-Point Patient-Reported. The Patient-Reported Hair Loss assessment includes 5 categories to assess how much of the patient's scalp is missing hair. Reported on a scale of 0-4, with 0 being no hair loss, and 4 nearly all or all hair loss.
Time frame: Baseline (pre-treatment), 12 weeks (post-treatment)
Patient Reported Hair Regrowth
The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. Reported on a scale of 0-4, with 0 being no regrowth, and 4 being 100% regrowth.
Time frame: 12 weeks
Change in Severity of Alopecia Tool (SALT) Score
SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss.
Time frame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)
AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss.
Time frame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
Hair Regrowth of Treated Patch
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Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Time frame: 12 weeks
Hair Regrowth of Non-treated Patch
Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Time frame: 12 weeks
Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.
At each visit, subjects will answer either the Children's Dermatology Quality of Life Index (cCDLQI) (ages 6-11) or the Teenager's Quality of Life Index (T-QoL) (ages 12-17). Both the cCDLQI and T-QoL have the same scale ranges and directionality- 10 item questionnaire asking about skin troubles on a scale of 1-4, with 1 being "not at all" and 4 being "very much".
Time frame: Baseline (pre-treatment), 12 weeks (post-treatment)