What side effects are associated with this type of intervention?

Intralesional triamcinolone acetonide (ILTA) can cause skin atrophy, telangiectasia, and hypopigmentation at the injection site. Topical corticosteroids may lead to skin thinning, stretch marks, and local irritation. Minoxidil is generally well-tolerated but can cause unwanted facial hair growth and dermatitis. Cyclosporine, while potentially effective, carries risks of serious side effects such as hypertension, kidney dysfunction, and increased susceptibility to infections. Methotrexate can cause liver toxicity, bone marrow suppression, and gastrointestinal issues. These side effects necessitate careful monitoring during treatment.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for alopecia areata. However, various treatments are used off-label, including corticosteroids like triamcinolone acetonide, which can be administered intralesionally. The Med-Jet trial is exploring a needle-free delivery method for ILTA, aiming to improve tolerability and patient experience. Other treatments under investigation include JAK inhibitors, which are in advanced clinical trials but not yet FDA-approved for alopecia areata.

What other types of research exist?

Promising alternatives to Med-Jet for Alopecia Areata treatment in 2024 include: 1) Low-Level Laser Therapy (LLLT), which stimulates hair growth through photobiomodulation. 2) Platelet-Rich Plasma (PRP) therapy, which uses concentrated platelets to promote hair regrowth. 3) Microneedling combined with topical treatments, enhancing drug delivery and stimulating hair follicles. 4) New oral medications like JAK inhibitors (e.g., tofacitinib and ruxolitinib) that target immune pathways involved in Alopecia Areata.

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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

Must not have

Patient has alopecia totalis, alopecia universalis, or alopecia areata with ophiasis pattern

Patient is unable/unwilling to provide informed assent when applicable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing a needle-free device called Med-Jet to give medicine to children with patchy hair loss. The device uses pressure instead of needles, which might be less painful and more effective.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have total hair loss, universal hair loss, or a specific pattern of hair loss called ophiasis.

Select...

You have a medical condition or take a medication that affects how you feel pain when getting an injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Change in Patient Reported Hair Loss

Change in Severity of Alopecia Tool (SALT) Score

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial 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).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alopecia Areata include intralesional corticosteroids like triamcinolone acetonide, which work by reducing inflammation and modulating the immune response that attacks hair follicles. Topical immunotherapies such as diphenylcyclopropenone (DPCP) and squaric acid dibutyl ester (SADBE) induce a mild allergic reaction to divert the immune system from attacking hair follicles. Systemic immunosuppressants like methotrexate and cyclosporine suppress the overall immune response to prevent hair loss. These mechanisms are crucial for patients as they target the underlying autoimmune process, offering potential for hair regrowth and improving quality of life.

Multi-Concentration Level Patch Test Guided Diphenyl Cyclopropenone (DPCP) Treatment in Alopecia Totalis or Alopecia Universalis.Interventions for alopecia areata.