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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410237
• Other study ID #: STUDY20200508
• Status: Completed
• Phase: Early Phase 1
• Start date: November 4, 2020
• Est. completion date: May 19, 2023

Study information

• Verified date: September 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	26 Weeks
Secondary	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.	26 Weeks
Secondary	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.	26 Weeks
Secondary	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.	26 weeks