Status:
COMPLETED
Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04410237
Start Date
November 4 2020
End Date
May 19 2023
Last Update
September 18 2023
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106