Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability

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.

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Combination product: MedJet Device with intralesional triamcinolone

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Patient Tolerability of Needle-free Delivery of Intralesional Triamcinolone Using the Patient-reported Outcomes of a Pain Score Assessment and a Patient Survey.	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Reported Hair Loss	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.	Baseline (pre-treatment), 12 weeks (post-treatment)
Patient Reported Hair Regrowth	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.	12 weeks
Change in Severity of Alopecia Tool (SALT) Score	SALT Score is a score of 0-100, where 0 is no hair loss, and 100 is complete hair loss.	Baseline (Pre-treatment), 12 weeks (Post-treatment)
Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)	AA-IGA is measured on a score of 1-5, with 1 being mild hair loss, to 5 being severe hair loss.	Baseline (Pre-treatment), 12 weeks (Post-treatment)
Hair Regrowth of Treated Patch	Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss	12 weeks
Hair Regrowth of Non-treated Patch	Scored on a 0-5 scale, with 5 being complete regrowth and 0 being further hair loss	12 weeks
Determine the Impact of Needle-free Delivery of Intralesional Triamcinolone on Quality of Life for Pediatric Alopecia Areata Using a Quality of Life Assessment.	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".	Baseline (pre-treatment), 12 weeks (post-treatment)

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Sonal Shah, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: 20211626

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No