Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospitals Cleveland Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Neil Korman, MD, PhD|
|Principal Investigator Affiliation||University Hospitals Cleveland Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Active Comparator: Traditional Syringe
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.
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