Last updated: January 30, 2024
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Terminated
Phase
4
Condition
Alopecia
Hair Loss
Treatment
MedJet Device with intralesional triamcinolone
Clinical Study ID
NCT05278858
20211626
Ages 6-17 All Genders
Study Summary
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 StatesSite Not Available
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