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Trial record 2 of 2 for:    MED-JET

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410237
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Psoriasis Device: Med-Jet Other: Traditional Syringe Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System: an Observational Pilot Study
Estimated Study Start Date : November 4, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410237


Contacts
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Contact: Joseph Kamel, MD 216-844-7834 Joseph.Kamel@UHhospitals.org
Contact: Amanda Davies, BS 216-844-7834 Amanda.Davies@UHhospitals.org

Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Neil Korman, MD, PhD University Hospitals Cleveland Medical Center
Publications:

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Responsible Party: Neil Korman, Principle Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT04410237    
Other Study ID Numbers: STUDY20200508
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neil Korman, University Hospitals Cleveland Medical Center:
Triamcinolone Acetonide
Med-Jet
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases