Psoriasis Clinical Trial

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

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 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

13

Study ID:

NCT04410237

Recruitment Status:

Completed

Sponsor:

University Hospitals Cleveland Medical Center

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There is 1 Location for this study

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University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Early Phase 1

Estimated Enrollment:

13

Study ID:

NCT04410237

Recruitment Status:

Completed

Sponsor:


University Hospitals Cleveland Medical Center

How clear is this clinincal trial information?

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