Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

NCT ID: NCT05278858

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2023-06-06

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MedJet Device

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).

Group Type: EXPERIMENTAL

MedJet Device with intralesional triamcinolone

Intervention Type: COMBINATION_PRODUCT

A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated.

Interventions

MedJet Device with intralesional triamcinolone

A standard sterile disposable 5 ml syringe will be used to draw TAC using standard sterile protocol. This syringe will be attached to the Med-Jet along with a sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection pressure used on the subject will start at 110 pounds per square inch (psi) and increased by 10 psi until a blanching wheal is observed. The optimal pressure will be recorded. The injections will be repeated multiple times at the optimal pressure until the targeted patch is completely treated.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonal Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20211626

Identifier Type: -

Identifier Source: org_study_id