Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

University Hospitals (UH)

Status and phase: Terminated; Phase 4

Conditions: Alopecia Areata

Treatments: Combination Product: MedJet Device with intralesional triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05278858

20211626

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

MedJet Device

Experimental group

Description:

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).

Treatment:

Combination Product: MedJet Device with intralesional triamcinolone