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Med-Jet, Traditional Syringe · 1 trial · 1 indication
Validate the safety of the Med-jet needle-free drug-delivery system in combination with triamcinolone acetonide in patients with mild-to-moderate psoriasis.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
| 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 |
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 psoriasi...