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Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MedJet Device with intralesional triamcinolone
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alopecia Areata focused on measuring Pediatric

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MedJet Device

Arm 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).

Outcomes

Primary Outcome Measures

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. The patient survey will be done at each visit and will assess the perceived tolerability, comfortability, associated fear, and experience and preference for the needle-free injector versus a conventional needle and syringe.

Secondary Outcome Measures

Determine the efficacy of needle-free delivery of intralesional triamcinolone for pediatric alopecia areata using patient-reported efficacy assessments and physician efficacy assessments
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. The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. The physician assessments consist of the Severity of Alopecia Tool (SALT) Score, the Alopecia Areata - Investigator Global Assessment (AA-IGA), and the "Rule of Thumb" Assessment and Regrowth Categorization. The SALT Score is a visual tool to assess percentage of hair loss on the scalp. The AA-IGA categorizes scalp hair loss into 5 categories it is a static tool and quantifies the hair loss at one point in time. The "Rule of Thumb" is used to quantify the percentage of total scalp hair loss contributed by each patch at baseline; the thumbprint projection from baseline will be used to determine percent of regrowth since baseline.
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). These questionnaires are designed to measure the impact of any skin disease on the lives of children and teens, and include questions on how the patient's skin disease affects different areas of their lives, including school, friendships, and sleep.

Full Information

First Posted
January 26, 2022
Last Updated
April 3, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05278858
Brief Title
Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata
Official Title
Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Pediatric

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MedJet Device
Arm Type
Experimental
Arm 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).
Intervention Type
Combination Product
Intervention Name(s)
MedJet Device with intralesional triamcinolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine patient tolerability of needle-free delivery of intralesional triamcinolone using the patient-reported outcomes of a pain score assessment and a patient survey.
Description
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. The patient survey will be done at each visit and will assess the perceived tolerability, comfortability, associated fear, and experience and preference for the needle-free injector versus a conventional needle and syringe.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Determine the efficacy of needle-free delivery of intralesional triamcinolone for pediatric alopecia areata using patient-reported efficacy assessments and physician efficacy assessments
Description
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. The 5-Point Patient-Reported Regrowth will ask the subject about their perceived amount of hair regrowth. The physician assessments consist of the Severity of Alopecia Tool (SALT) Score, the Alopecia Areata - Investigator Global Assessment (AA-IGA), and the "Rule of Thumb" Assessment and Regrowth Categorization. The SALT Score is a visual tool to assess percentage of hair loss on the scalp. The AA-IGA categorizes scalp hair loss into 5 categories it is a static tool and quantifies the hair loss at one point in time. The "Rule of Thumb" is used to quantify the percentage of total scalp hair loss contributed by each patch at baseline; the thumbprint projection from baseline will be used to determine percent of regrowth since baseline.
Time Frame
12 weeks
Title
Determine the impact of needle-free delivery of intralesional triamcinolone on quality of life for pediatric alopecia areata using a quality of life assessment.
Description
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). These questionnaires are designed to measure the impact of any skin disease on the lives of children and teens, and include questions on how the patient's skin disease affects different areas of their lives, including school, friendships, and sleep.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kory Schrom, MD
Phone
216-844-7834
Email
Kory.Schrom@Uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Kahle
Phone
216-844-7305
Email
Jordan.Kahle@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonal Shah, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kory Schrom, MD
Phone
216-844-5728
Email
Kory.Schrom@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jordan Kahle, MD
Phone
216-844-7305
Email
Jordan.Kahle@UHhospitals.org

12. IPD Sharing Statement

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Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata

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