Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System: an Observational Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Med-Jet
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
干预措施: Med-Jet (Device)
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.
干预措施: Traditional Syringe (Other)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCASE v5.0
时间窗: 26 Weeks
Validate the safety of the Med-jet needle-free drug-delivery system in combination with triamcinolone acetonide in patients with mild-to-moderate psoriasis.
次要结局
- Efficacy as measured by the target physician global assessment(26 Weeks)
- Tolerability as measured by the visual analog pain scores(26 Weeks)
- Pruritus as measured by visual analog pruritus scale(26 weeks)
- Quality of Life metric as assessed by the dermatology life quality assessment(26 Weeks)
研究者
Neil Korman
Principle Investigator
University Hospitals Cleveland Medical Center