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Med-Jet for Psoriasis
Phase < 1
Waitlist Available
Led By Neil Korman, MD, PhD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Study Summary
This trial is testing a new needle-free drug delivery system for psoriasis patients. The hypothesis is that it will be at least as effective as the current needle-and-syringe method, with possibly fewer side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
Secondary outcome measures
Efficacy as measured by the target physician global assessment
Pruritus as measured by visual analog pruritus scale
Quality of Life metric as assessed by the dermatology life quality assessment
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Med-JetExperimental Treatment1 Intervention
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
Group II: Traditional SyringeActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Med-Jet
2020
Completed Early Phase 1
~20
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,244 Total Patients Enrolled
7 Trials studying Psoriasis
178 Patients Enrolled for Psoriasis
Neil Korman, MD, PhDPrincipal Investigator - University Hospitals Cleveland Medical Center
University Hospital Dermatology Associates Inc, University Hospitals Case Medical Center, University Hospitals MacDonald Women's Hospital, University Hospitals Rainbow Babies & Children's Hospital
Case Western Reserve University School Of Medicine (Medical School)
University Hosp Of Cleveland (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used tanning booths within 4 weeks before the first visit of the study.You have at least two plaques of psoriasis that are at least 2 cm² in size on your trunk, buttocks, or arms and legs. These plaques may be symmetrical on opposite sides of your body or may be located within the same area but separated by at least 1 cm.You are currently taking medication or have a medical condition that may affect your immune system or ability to heal wounds.You have been diagnosed with plaque-type psoriasis by a dermatologist, nurse practitioner specializing in dermatology, or by a skin punch biopsy.You have used certain types of skin medication or therapy on the areas being studied within the past 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Med-Jet
- Group 2: Traditional Syringe
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots still open for this clinical trial?
"That is correct, the online clinicaltrial registry does show that the research is currently looking for volunteers. The 30 participants will be drawn from a single location, and the study's most recent update was on June 30th, 2022."
Answered by AI
How many individuals are signed up to take part in this research project?
"That is correct. According to the latest update on clinicaltrials.gov, this trial was posted on 11/4/2020 and is currently seeking 30 patients from 1 location."
Answered by AI
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