An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin Surface Temperature Change
研究概览
简要总结
Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Unlike more potent steroid products, T Spray has no time limitations on its use; therefore, it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis, and contact dermatitis.
In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas of the body. Its optional nozzle directs application of the medication to precise areas without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions on the scalp, back, intertriginous folds, large areas, or areas that require precise application would benefit from the T Spray formulation. In the time since the introduction of T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray remains the only mid-potency corticosteroid available in a spray formulation.
In a recently published open-label, non-comparator study involving 42 patients with chronic steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days. Improvement of lesions after one week of treatment was experienced by 85% of patients, and 95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of patients reported an anti-pruritic cooling effect which was experienced upon application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be at least 18 years old and in good general health, as confirmed by a medical history
- •A clear diagnosis of the chronic steroid-responsive dermatosis (i.e. psoriasis, atopic dermatitis) or acute steroid-responsive dermatosis (i.e. contact dermatitis, first-degree burn) must have been previously established and patients must have a target lesion that can be assessed for severity of inflammation
- •Females of childbearing potential must have a negative urine pregnancy test to participate in the study
- •Subjects must be able to understand the requirements of the study and sign an informed consent prior to study procedures
排除标准
- •Subjects who are pregnant and/or nursing
- •Subjects with a known hypersensitivity to any component of the T Spray
- •Subjects who are using any medication or have a disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
- •Subjects with any of the following pathologies: cold urticaria, cryoglobulinemia, Raynaud's phenomena, or Paroxysmal cold hemoglobulinuria
研究组 & 干预措施
Acute Steroid Responsive dermatitis
10 patients with acute steroid-responsive dermatoses
干预措施: Triamcinolone Acetonide spray (Drug)
Acute Steroid Responsive dermatitis
10 patients with acute steroid-responsive dermatoses
干预措施: Triamcinolone acetonide cream (Drug)
Acute Steroid Responsive dermatitis
10 patients with acute steroid-responsive dermatoses
干预措施: Alcohol spray (Drug)
Chronic Steroid Responsive Dermatits
10 patients with chronic steroid-responsive dermatoses
干预措施: Triamcinolone Acetonide spray (Drug)
Chronic Steroid Responsive Dermatits
10 patients with chronic steroid-responsive dermatoses
干预措施: Triamcinolone acetonide cream (Drug)
Chronic Steroid Responsive Dermatits
10 patients with chronic steroid-responsive dermatoses
干预措施: Alcohol spray (Drug)
Control, Otherwise healthy
10 healthy controls
干预措施: Triamcinolone Acetonide spray (Drug)
Control, Otherwise healthy
10 healthy controls
干预措施: Triamcinolone acetonide cream (Drug)
Control, Otherwise healthy
10 healthy controls
干预措施: Alcohol spray (Drug)
结局指标
主要结局
Skin Surface Temperature Change
时间窗: 1 month
By using an infrared video camera, to assess whether Triamcinolone Acetonide Spray's (T Spray) reduces in skin surface temperature (SST) when applied as indicated, for a two-second spray interval, to either acute or chronic steroid-responsive dermatoses
次要结局
未报告次要终点
