Clinical trial NCT04410237: Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System
Official title: Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System: an Observational Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Psoriasis
Keywords: Triamcinolone Acetonide
Med-Jet
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
timeFrame: 26 Weeks
Secondary outcomes:
measure: Efficacy as measured by the target physician global assessment
timeFrame: 26 Weeks
measure: Tolerability as measured by the visual analog pain scores
timeFrame: 26 Weeks
measure: Quality of Life metric as assessed by the dermatology life quality assessment
timeFrame: 26 Weeks
measure: Pruritus as measured by visual analog pruritus scale
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Neil Korman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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