Status:
TERMINATED
Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Alopecia Areata
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05278858
Start Date
March 24 2022
End Date
June 6 2023
Last Update
January 31 2024
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106