Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

NCT05278858 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 20211626
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Patient Reported Hair Loss

  Baseline (pre-treatment), 12 weeks (post-treatment)

• Patient Reported Hair Regrowth

  12 weeks

• Change in Severity of Alopecia Tool (SALT) Score

  Baseline (Pre-treatment), 12 weeks (Post-treatment)

• Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)

  Baseline (Pre-treatment), 12 weeks (Post-treatment)

• Hair Regrowth of Treated Patch

  12 weeks

Study Arms (1)

MedJet Device

EXPERIMENTAL

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

Interventions

MedJet Device with intralesional triamcinolone 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.

MedJet Device

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Sonal Shah, Director of Pediatric Dermatology
• Organization: University Hospitals Cleveland Medical Center

Sonal.Shah@UHhospitals.org

216-286-7285

Study Officials

• Sonal Shah, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 14, 2022
• Study Start: March 24, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Locations

US (1)