A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Response as assessed by Investigator Global Assessment (IGA)
研究概览
简要总结
The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
详细描述
Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial.
The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.
This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Clinical diagnosis of stable chronic hand dermatitis (greater than 6 weeks duration) that is KOH-negative
- •Dermatitis of mild to moderate severity, as defined by an Investigator's Global Assessment (a score of 2 or 3 on the Target Hand)
- •Individual signs of hand dermatitis disease of at least mild scaling and mild erythema (a score of 2 or more on the Target Hand)
- •Written informed consent
排除标准
- •Subject is female and is pregnant, lactating, or is planning to become pregnant during the study
- •Spontaneously improving or rapidly deteriorating hand dermatitis at the time of enrollment; subject may have history of waxing and waning disease in the past
- •History of hand dermatitis that has been shown to be unresponsive to super potent (Group 1) topical steroids
- •Concurrent flaring of inflammatory skin disease (e.g., atopic dermatitis or psoriasis) anywhere on the body outside the study areas
- •Bullous disorders or hand, foot, and mouth disease (HFMD); however, subjects with dyshidrotic hand dermatitis or pompholyx are allowed to participate provided they meet all other Inclusion/Exclusion criteria
- •Known allergic mediated hand dermatitis (e.g., allergic to latex, etc.)
- •Concurrent skin diseases in the study area that require concomitant topical treatment (e.g., tinea manuum, scabies, infected eczema, and paronychia) that could interfere with the evaluation of his/her dermatitis
- •Pustular diseases of the hands (e.g., acrodermatitis perstans continua).
- •Used photo-therapy, photo-chemotherapy, systemic immunomodulatory therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine), or other therapy within 30 days prior to the first application of study medication that is known or suspected, in the opinion of the investigator, to have an effect on hand dermatitis
- •Prolonged exposure to natural or artificial sources (e.g., UVB, UVA, etc.) of ultraviolet radiation within 30 days prior to the first application of study medication or is intending to have such exposure during the study
- •Received intralesional therapy to the hands (e.g., corticosteroids) within 30 days prior to first application of study medication
- •Treated with Grenz ray or soft x-ray therapy to the hands within 6 months of first application of study medication
- •Treated with topical hand therapy (e.g., tar, topical corticosteroids, topical retinoids, topical antimicrobials, topical calcineurin inhibitors, Burrow's solution soaks) within 7 days prior to first application of study medication that is known or suspected to have an effect on hand dermatitis
- •Received systemic antibiotics for infections of the hands within 7 days prior to the first application of study medication
研究组 & 干预措施
Triamcinolone Acetonide (TAC) DuraPeel
干预措施: Triamcinolone Acetonide (TAC) DuraPeel (Drug)
Placebo
干预措施: Placebo DuraPeel (Drug)
结局指标
主要结局
Response as assessed by Investigator Global Assessment (IGA)
时间窗: Baseline, Week 1, Week 2, Week 4
次要结局
- Subject's Global Impression of Change (SGIC)(Week 4 (end-of-treatment))
- Individual Primary Parameters of Hand Dermatitis(Baseline, Week 1, Week 2, Week 4)
- Signs or symptoms of hand dermatitis(Baseline, Week 1, Week 2, Week 4)
- Subject's self-assessment of overall hand disease(Baseline, Week 4)
- Study medication assessment(Week 1, Week 2, Week 4)