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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriasis

Intervention / Treatment
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* Device: Med-Jet
* Other: Traditional Syringe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Med-Jet<br>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<br>* 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<br>|
| Active Comparator: Traditional Syringe<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triamcinolone Acetonide, Med-Jet