Clinical trial NCT05278858: Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata
Official title: Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alopecia Areata
Keywords: Pediatric
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Primary outcomes:
measure: Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Patient Reported Hair Loss
timeFrame: Baseline (pre-treatment), 12 weeks (post-treatment)
measure: Patient Reported Hair Regrowth
timeFrame: 12 weeks
measure: Change in Severity of Alopecia Tool (SALT) Score
timeFrame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
measure: Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)
timeFrame: Baseline (Pre-treatment), 12 weeks (Post-treatment)
measure: Hair Regrowth of Treated Patch
timeFrame: 12 weeks
measure: Hair Regrowth of Non-treated Patch
timeFrame: 12 weeks
measure: Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.
timeFrame: Baseline (pre-treatment), 12 weeks (post-treatment)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Sonal Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: