Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

Study Overview
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Brief Summary
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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.

Official Title
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Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability

Conditions
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Alopecia Areata

Intervention / Treatment
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* Combination Product: MedJet Device with intralesional triamcinolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with alopecia areata by either: A board-certified dermatologist, OR Dermatology Nurse Practitioner, OR Skin punch biopsy Patient has at least 2 alopecic patches each measuring at least 2 cm2 and are… Located on contralateral body sites OR Within the same body site but separated by ≥ 1 cm Patient is a candidate for intralesional triamcinolone. Patient able to give informed assent under IRB approval procedures when appropriate. At least one parent or guardian is able to provide informed consent. Exclusion Criteria: Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasis pattern. Known allergy or hypersensitivity to triamcinolone acetonide Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. Patient is unable/unwilling to provide informed assent when applicable. Known medical diagnosis or use of a medication that alters pain response at time of injection. Active infection at site designated for injection. If currently being treated for alopecia areata, the current treatment regimen has been started within less than 4 weeks of screening.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedJet Device<br>The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005 orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet). | Combination Product: MedJet Device with intralesional triamcinolone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. The patient survey will be done at each visit and will assess the perceived tolerability, comfortability, associated fear, and experience and preference for the needle-free injector versus a conventional needle and syringe. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of needle-free delivery of intralesional triamcinolone for pediatric alopecia areata using patient-reported efficacy assessments and physician efficacy assessments | 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. The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. The physician assessments consist of the Severity of Alopecia Tool (SALT) Score, the Alopecia Areata - Investigator Global Assessment (AA-IGA), and the Rule of Thumb Assessment and Regrowth Categorization. The SALT Score is a visual tool to assess percentage of hair loss on the scalp. The AA-IGA categorizes scalp hair loss into 5 categories it is a static tool and quantifies the hair loss at one point in time. The Rule of Thumb is used to quantify the percentage of total scalp hair loss contributed by each patch at baseline; the thumbprint projection from baseline will be used to determine percent of regrowth since baseline. | 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). These questionnaires are designed to measure the impact of any skin disease on the lives of children and teens, and include questions on how the patient's skin disease affects different areas of their lives, including school, friendships, and sleep. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric