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Corticosteroid
Needle-free Triamcinolone for Alopecia Areata
Phase 4
Waitlist Available
Led By Sonal Shah, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test a needle-free delivery system for a medication to treat pediatric alopecia areata. They hope it is effective and has a positive impact on patient quality of life.
Who is the study for?
This trial is for children with patchy hair loss (alopecia areata) who have at least two bald patches and can receive a treatment without needles. They must be diagnosed by a specialist or through a skin biopsy, and not have total hair loss or certain patterns of alopecia. Kids taking meds that affect pain sensation, those allergic to the medication used, pregnant teens, or those with an infection where the drug will go can't join.Check my eligibility
What is being tested?
The study tests if using the MedJet device to deliver triamcinolone (a steroid) without needles is bearable for kids with alopecia areata. It checks if this method works well and safely improves their quality of life over four to five visits.See study design
What are the potential side effects?
Possible side effects include discomfort from the needle-free device and reactions to triamcinolone like skin thinning at the treated area, changes in color on site of injection, headache, stuffy nose, sore throat or coughing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have at least two bald patches, each measuring at least 2 square centimeters.
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The things being studied are either on opposite sides of the body or are at least 1 centimeter apart on the same side.
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You have at least 2 bald patches on different sides of your body, or on the same side but at least 1 cm apart.
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You have at least 2 bald patches, each at least the size of a quarter, on different parts of your body or at least 1 inch apart on the same body part.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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.
Secondary outcome measures
Change in Alopecia Areata- Investigator Global Assessment (AA-IGA)
Change in Patient Reported Hair Loss
Change in Severity of Alopecia Tool (SALT) Score
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MedJet DeviceExperimental Treatment1 Intervention
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).
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Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
340,074 Total Patients Enrolled
1 Trials studying Alopecia Areata
14 Patients Enrolled for Alopecia Areata
Sonal Shah, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are eligible for receiving a specific type of injection called intralesional triamcinolone.You have at least two bald patches, each measuring at least 2 square centimeters.You are able to provide informed consent.You are able to give informed assent under IRB approval procedures when appropriate.You have been diagnosed with alopecia areata by a certified skin doctor or through a skin biopsy.You have at least 2 bald patches, each at least the size of a quarter, on different parts of your body or at least 1 inch apart on the same body part.You have at least 2 bald patches on different sides of your body, or on the same side but at least 1 cm apart.You have a medical condition or take a medication that affects how you feel pain when getting an injection.The patient needs treatment with triamcinolone injected directly into a specific area.You are allergic to triamcinolone acetonide.A doctor or nurse practitioner who specializes in skin conditions or a skin biopsy will be used to confirm eligibility.You have total hair loss, universal hair loss, or a specific pattern of hair loss called ophiasis.You have an ongoing infection where the injection is supposed to be given.The things being studied are either on opposite sides of the body or are at least 1 centimeter apart on the same side.If you are currently receiving treatment for alopecia areata, you must have started the treatment less than 4 weeks before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: MedJet Device
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT05278858 — Phase 4
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