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临床试验/NCT01736670
NCT01736670已完成不适用

An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses

Patel, Rita Vikram, M.D.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

10 patients with acute steroid-responsive dermatoses

干预措施: Triamcinolone Acetonide spray (Drug)

Acute Steroid Responsive dermatitis

Experimental

10 patients with acute steroid-responsive dermatoses

干预措施: Triamcinolone acetonide cream (Drug)

Acute Steroid Responsive dermatitis

Experimental

10 patients with acute steroid-responsive dermatoses

干预措施: Alcohol spray (Drug)

Chronic Steroid Responsive Dermatits

Experimental

10 patients with chronic steroid-responsive dermatoses

干预措施: Triamcinolone Acetonide spray (Drug)

Chronic Steroid Responsive Dermatits

Experimental

10 patients with chronic steroid-responsive dermatoses

干预措施: Triamcinolone acetonide cream (Drug)

Chronic Steroid Responsive Dermatits

Experimental

10 patients with chronic steroid-responsive dermatoses

干预措施: Alcohol spray (Drug)

Control, Otherwise healthy

Active Comparator

10 healthy controls

干预措施: Triamcinolone Acetonide spray (Drug)

Control, Otherwise healthy

Active Comparator

10 healthy controls

干预措施: Triamcinolone acetonide cream (Drug)

Control, Otherwise healthy

Active Comparator

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

研究者

发起方
Patel, Rita Vikram, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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