NCT04410237

Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System

Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System: an Observational Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational pilot study comparing triamcinolone acetonide injections with the investigational Med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. There will be five (5) visits necessary for study participation. The hypothesis is that the efficacy, safety, pain tolerance, and quality of life (QoL) metrics of the Med-jet needle-free drug-delivery system will be equal to or superior to that of a conventional syringe and needle.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DEVICE	Med-Jet	One half of each psoriasis plaque will be treated with a Med-Jet device and Triamcinolone acetonide (TAC) while the control half will be untreated. One side of the body will be treated using a conventional syringe and the opposite side of the body will be treated using the Med-Jet needle-free injection device to verify efficacy, safety, and pain score
OTHER	Traditional Syringe	One half of each psoriasis plaque will be treated with a traditional syringe and Triamcinolone acetonide (TAC) while the control half will be untreated. One side of the body will be treated using conventional syringe and the opposite side of the body will be treated using the Med-Jet needle-free injection device to verify efficacy, safety, and pain score

Timeline

• Start date: 2020-11-04
• Primary completion: 2023-05-19
• Completion: 2023-05-19
• First posted: 2020-06-01
• Last updated: 2023-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study