Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: MedJet Device with intralesional triamcinolone
Intervention description: 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.
Intervention MeSH terms: Triamcinolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric

Summary:

      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.
    

Eligibility criteria:

        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.