Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    15
  • sponsor
    University Hospitals Cleveland Medical Center
Updated on 23 April 2022
areata alopecia

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.

Details
Condition Alopecia Areata
Treatment MedJet Device with intralesional triamcinolone
Clinical Study IdentifierNCT05278858
SponsorUniversity Hospitals Cleveland Medical Center
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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