Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

Last updated: January 30, 2024
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Terminated

Phase

4

Condition

Hair Loss

Alopecia

Treatment

MedJet Device with intralesional triamcinolone

Clinical Study ID

NCT05278858
20211626
  • Ages 6-17
  • All Genders

Study 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

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

Exclusion Criteria:

  • Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasispattern.
  • Known allergy or hypersensitivity to triamcinolone acetonide
  • Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4weeks 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 ofinjection.
  • Active infection at site designated for injection.
  • If currently being treated for alopecia areata, the current treatment regimen has beenstarted within less than 4 weeks of screening.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: MedJet Device with intralesional triamcinolone
Phase: 4
Study Start date:
March 24, 2022
Estimated Completion Date:
June 06, 2023

Connect with a study center

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

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