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

NCT04410237 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-09-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Neil Korman, MD, PhD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-05-19
Completion
2023-05-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04410237 on ClinicalTrials.gov