Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

Phase 4

Terminated

Conditions: Alopecia Areata

Interventions: Combination Product: MedJet Device with intralesional triamcinolone

Registration Number: NCT05278858

Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MedJet Device	MedJet Device with intralesional triamcinolone	The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air as a power source to accelerate an injectable fluid through a 0.005" orifice (6x smaller than a 30G needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas (MedJet).

Primary Outcome Measures

Name	Time	Method
Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.	12 weeks	For the pain score assessment, patients will rate their pain from the needle-free injection using the Wong-Baker FACES Scale and a numerical rating scale, in which score ranges from 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Change in Patient Reported Hair Loss	Baseline (pre-treatment), 12 weeks (post-treatment)	The patient-reported efficacy assessments will consist of the Patient-Reported Hair Loss and the 5-Point Patient-Reported. The Patient-Reported Hair Loss assessment includes 5 categories to assess how much of the patient's scalp is missing hair. Reported on a scale of 0-4, with 0 being no hair loss, and 4 nearly all or all hair loss.
Change in Severity of Alopecia Tool (SALT) Score	Baseline (Pre-treatment), 12 weeks (Post-treatment)	SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss.
Hair Regrowth of Treated Patch	12 weeks	Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)	Baseline (Pre-treatment), 12 weeks (Post-treatment)	AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss.
Hair Regrowth of Non-treated Patch	12 weeks	Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss
Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.	Baseline (pre-treatment), 12 weeks (post-treatment)	At each visit, subjects will answer either the Children's Dermatology Quality of Life Index (cCDLQI) (ages 6-11) or the Teenager's Quality of Life Index (T-QoL) (ages 12-17). Both the cCDLQI and T-QoL have the same scale ranges and directionality- 10 item questionnaire asking about skin troubles on a scale of 1-4, with 1 being "not at all" and 4 being "very much".
Patient Reported Hair Regrowth	12 weeks	The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. Reported on a scale of 0-4, with 0 being no regrowth, and 4 being 100% regrowth.