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

September 15, 2023 updated by: Neil Korman, University Hospitals Cleveland Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with plaque-type psoriasis defined by either:

    • A board-certified dermatologist, OR
    • Dermatology Nurse Practitioner, OR
    • Skin punch biopsy
  • Involvement of body surface area (BSA) < 10% at screening and baseline visit.

  • The presence of plaque-type psoriasis at least two (2) plaques that are at least two (2) cm² in areas of the trunk, buttock, or extremities that are either:

    • Symmetrically located on contralateral body site OR
    • Within the same body site but separated by ≥ 1 cm
  • Able to give informed consent under IRB approval procedures

Exclusion Criteria:

  • Known allergy or hypersensitivity to triamcinolone acetonide
  • Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
  • Inability to provide informed consent
  • Active untreated diseases or medication usage which may interfere with wound healing and immune function (anti-neoplastic, systemic immunosuppressants, anticoagulants, daily NSAIDS)
  • Use of tanning booths for at least 4 weeks prior to baseline visit
  • Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit
  • Current or recent use of systemic or biologic therapy for at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Med-Jet
The Med-Jet injector is a novel needle-free drug-delivery system, which we believe may be a solution to the impracticalities of ILTA for mild-to-moderate psoriasis. 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.12 The drug-delivery device is highly configurable allowing adjustable depth and volume parameters.12 In addition, the high-performance design allows for triggering multiple injection sites rapidly which is practical when needing to treat large surface areas
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
Active Comparator: Traditional Syringe
TAC will be injected on a half-plaque while the control half of the plaque will be untreated. A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
Time Frame: 26 Weeks
Validate the safety of the Med-jet needle-free drug-delivery system in combination with triamcinolone acetonide in patients with mild-to-moderate psoriasis.
26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy as measured by the target physician global assessment
Time Frame: 26 Weeks
Validate efficacy as alternatives to using triamcinolone acetonide with a conventional needle and syringe in patients with mild-to-moderate psoriasis as measured by the target physician global assessment (tPGA). tPGA is a 5 point scale (0-4) 0 meaning clear skin and 4 meaning severe skin.
26 Weeks
Tolerability as measured by the visual analog pain scores
Time Frame: 26 Weeks
Validate tolerability as alternatives to using triamcinolone acetonide with a conventional needle and syringe in patients with mild-to-moderate psoriasis as measured by the visual analog pain scores. Measured on a scale of 0 to 10, where 0 is no distress and 10 is unbearable distress.
26 Weeks
Quality of Life metric as assessed by the dermatology life quality assessment
Time Frame: 26 Weeks
Validate quality of life metrics as alternatives to using triamcinolone acetonide with a conventional needle and syringe in patients with mild-to-moderate psoriasis as measured by the dermatology life quality assessment (DLQI). DLQI is 0 to 30 scale, where 0 is no effect on patient life and 30 is an extremely large effect on patient life.
26 Weeks
Pruritus as measured by visual analog pruritus scale
Time Frame: 26 weeks
Validate pruritus as alternatives to using triamcinolone acetonide with a conventional needle and syringe in patients with mild-to-moderate psoriasis as measured by the visual analog pruritus scale, measured on a scale of 0 to 10 where 0 is no itch and 10 is the worst itch imaginable.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Neil Korman, MD, PhD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2020

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

May 19, 2023

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20200508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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