Your session is about to expire
← Back to Search
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.
Select...
The things being studied are either on opposite sides of the body or are at least 1 centimeter apart on the same side.
Select...
You have at least 2 bald patches on different sides of your body, or on the same side but at least 1 cm apart.
Select...
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).
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,254 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:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of participants in this experiment?
"Affirmative. Clinicaltrials.gov documents that this investigation is actively enrolling patients, having been first posted on March 24th 2022 and last amended April 1st 2022. The research requires 15 participants to be recruited from one medical centre."
Answered by AI
Are there still available slots in this research project for volunteers?
"Per the data on clinicaltrials.gov, this medical experiment is still enrolling volunteers. The trial was initially shared with the public on March 24th 2022 and its details were most recently updated April 1st of the same year."
Answered by AI
Has the MedJet Device with intralesional triamcinolone been approved by federal authorities?
"With a rating of 3, our team has determined that the MedJet Device with intralesional triamcinolone is safe and approved due to its Phase 4 trial status."
Answered by AI
Are individuals aged 45 and above being admitted to this research program?
"Patients eligible for this study must fall between the ages of 6 to 17. For individuals who are under 18, there are 9 separate studies available and 63 distinct trials for those over 65 years old."
Answered by AI
Is my participation in this experiment permissible?
"This clinical trial seeks 15 minors aged 6 to 17 who possess alopecia areata, and they must fulfil the following conditions - an appointment with a board-certified dermatologist or Dermatology Nurse Practitioner plus Skin punch biopsy; at least two patches of hair loss each measuring 2 cm2 on separate body parts separated by 1 cm; able to give assent when applicable for IRB approval procedures; one parent/guardian is capable of providing informed consent; patient must be eligible for intralesional triamcinolone."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University Hospitals Cleveland Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried steriod injections years ago and minoxidil that did not work for me.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University Hospitals Cleveland Medical Center: < 24 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger