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

NCT04410237 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: STUDY20200508
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Triamcinolone Acetonide; Med-Jet

Outcome Measures

Primary Outcomes (1)

• 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.

  26 Weeks

Secondary Outcomes (4)

• Efficacy as measured by the target physician global assessment

  26 Weeks

• Tolerability as measured by the visual analog pain scores

  26 Weeks

• Quality of Life metric as assessed by the dermatology life quality assessment

  26 Weeks

• Pruritus as measured by visual analog pruritus scale

  26 weeks

Study Arms (2)

Med-Jet

EXPERIMENTAL

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

Traditional Syringe

ACTIVE COMPARATOR

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

Interventions

Med-Jet DEVICE

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

Med-Jet

Traditional Syringe OTHER

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

Traditional Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (16)

• 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.

  PMID: 15627076 BACKGROUND

• 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.

  PMID: 23014338 BACKGROUND

• 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.

  PMID: 23925466 BACKGROUND

• 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.

  PMID: 15083780 BACKGROUND

• 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.

  PMID: 16274404 BACKGROUND

• 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.

  PMID: 27664969 BACKGROUND

• 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.

  PMID: 28755089 BACKGROUND

• 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.

  PMID: 13740078 BACKGROUND

• 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.

  PMID: 13905149 BACKGROUND

• 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.

  PMID: 13999537 BACKGROUND

• 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.

  PMID: 30109720 BACKGROUND

• 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.

  PMID: 13941443 BACKGROUND

• 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.

  PMID: 17271055 BACKGROUND

• 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.

  PMID: 26737989 BACKGROUND

• 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.

  PMID: 27893541 BACKGROUND

• 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.

  PMID: 24377472 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Neil Korman, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 1, 2020
• Study Start: November 4, 2020
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)