Needle-free Triamcinolone for Alopecia Areata

Recruiting in Palo Alto (17 mi)

Overseen bySonal Shah, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University Hospitals Cleveland Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Diagnosed with alopecia areata by either: A board-certified dermatologist, OR Dermatology Nurse Practitioner, OR Skin punch biopsy

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.

See 10 more

Exclusion Criteria

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

You are allergic to triamcinolone acetonide.

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

See 4 more

Treatment Details

Interventions

Intralesional Triamcinolone (Corticosteroid)
Needle-free Delivery (Procedure)

Trial OverviewThe 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.

Participant Groups

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).