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

Primary Purpose

Psoriasis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Med-Jet
Traditional Syringe
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis focused on measuring Triamcinolone Acetonide, Med-Jet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Med-Jet

Traditional Syringe

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
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

Efficacy as measured by the target physician global assessment
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.
Tolerability as measured by the visual analog pain scores
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.
Quality of Life metric as assessed by the dermatology life quality assessment
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.
Pruritus as measured by visual analog pruritus scale
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.

Full Information

First Posted
May 20, 2020
Last Updated
September 15, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04410237
Brief Title
Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System
Official Title
Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System: an Observational Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Triamcinolone Acetonide, Med-Jet

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Med-Jet
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional Syringe
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Med-Jet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Traditional Syringe
Intervention Description
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 Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
Description
Validate the safety of the Med-jet needle-free drug-delivery system in combination with triamcinolone acetonide in patients with mild-to-moderate psoriasis.
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
Efficacy as measured by the target physician global assessment
Description
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.
Time Frame
26 Weeks
Title
Tolerability as measured by the visual analog pain scores
Description
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.
Time Frame
26 Weeks
Title
Quality of Life metric as assessed by the dermatology life quality assessment
Description
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.
Time Frame
26 Weeks
Title
Pruritus as measured by visual analog pruritus scale
Description
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.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Korman, MD, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15627076
Citation
Gelfand JM, Stern RS, Nijsten T, Feldman SR, Thomas J, Kist J, Rolstad T, Margolis DJ. The prevalence of psoriasis in African Americans: results from a population-based study. J Am Acad Dermatol. 2005 Jan;52(1):23-6. doi: 10.1016/j.jaad.2004.07.045.
Results Reference
background
PubMed Identifier
23014338
Citation
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
Results Reference
background
PubMed Identifier
23925466
Citation
Yeung H, Takeshita J, Mehta NN, Kimmel SE, Ogdie A, Margolis DJ, Shin DB, Attor R, Troxel AB, Gelfand JM. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol. 2013 Oct;149(10):1173-9. doi: 10.1001/jamadermatol.2013.5015.
Results Reference
background
PubMed Identifier
15083780
Citation
Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc. 2004 Mar;9(2):136-9. doi: 10.1046/j.1087-0024.2003.09102.x.
Results Reference
background
PubMed Identifier
16274404
Citation
Fouere S, Adjadj L, Pawin H. How patients experience psoriasis: results from a European survey. J Eur Acad Dermatol Venereol. 2005 Nov;19 Suppl 3:2-6. doi: 10.1111/j.1468-3083.2005.01329.x.
Results Reference
background
PubMed Identifier
27664969
Citation
Alinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, Feldman SR. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017 Mar;176(3):759-764. doi: 10.1111/bjd.15085. Epub 2016 Nov 29.
Results Reference
background
PubMed Identifier
28755089
Citation
Kamel JG, Yamauchi PS. Managing Mild-to-Moderate Psoriasis in Elderly Patients: Role of Topical Treatments. Drugs Aging. 2017 Aug;34(8):583-588. doi: 10.1007/s40266-017-0480-8.
Results Reference
background
PubMed Identifier
13740078
Citation
READETT MD. Intralesional triamcinolone acetonide in the treatment of psoriasis. Br J Dermatol. 1961 Mar;73:107-9. doi: 10.1111/j.1365-2133.1961.tb14416.x. No abstract available.
Results Reference
background
PubMed Identifier
13905149
Citation
HASEGAWA J, LIVINGSTON W. The intralesional use of triamcinolone acetonide in psoriasis. A double blind study. Arch Dermatol. 1962 Feb;85:258-60. doi: 10.1001/archderm.1962.01590020098010. No abstract available.
Results Reference
background
PubMed Identifier
13999537
Citation
WEIDMAN AI. Treatment of psoriasis and other dermatoses with intralesional injections of triamcinolone acetonide. Curr Ther Res Clin Exp. 1963 Jan;5:7-11. No abstract available.
Results Reference
background
PubMed Identifier
30109720
Citation
McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
Results Reference
background
PubMed Identifier
13941443
Citation
PARISER H, MURRAY PF. Intralesional injections of triamcinolone. Effects of different concentrations on psoriatic lesions. Arch Dermatol. 1963 Feb;87:183-7. doi: 10.1001/archderm.1963.01590140045008. No abstract available.
Results Reference
background
PubMed Identifier
17271055
Citation
Schramm-Baxter JR, Mitragotri S. Investigations of needle-free jet injections. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:3543-6. doi: 10.1109/IEMBS.2004.1403996.
Results Reference
background
PubMed Identifier
26737989
Citation
Park G, Modak A, Hogan NC, Hunter IW. The effect of jet shape on jet injection. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7350-3. doi: 10.1109/EMBC.2015.7320089.
Results Reference
background
PubMed Identifier
27893541
Citation
Vadeboncoeur S, Richer V, Nantel-Battista M, Benohanian A. Treatment of Palmar Hyperhidrosis With Needle Injection Versus Low-Pressure Needle-Free Jet Injection of OnabotulinumtoxinA: An Open-Label Prospective Study. Dermatol Surg. 2017 Feb;43(2):264-269. doi: 10.1097/DSS.0000000000000970.
Results Reference
background
PubMed Identifier
24377472
Citation
Nantel-Battista M, Richer V, Marcil I, Benohanian A. Treatment of nail psoriasis with intralesional triamcinolone acetonide using a needle-free jet injector: a prospective trial. J Cutan Med Surg. 2014 Jan-Feb;18(1):38-42. doi: 10.2310/7750.2013.13078.
Results Reference
background

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

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