An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 169
- 主要终点
- Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)
研究概览
简要总结
The objectives of this study are to evaluate the dermal safety and on-body temperature of a disposable heatwrap product when worn while in a supine position for five consecutive days. The product will be worn on the back for approximately 8 hours per 24 hour period.
详细描述
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is a male or female in generally good health greater or equal to 35 years of age;
- •Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device, diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);
- •The subject has a waist-hip circumference of between 27-47 inches inclusive.
排除标准
- •The subject is a pregnant or lactating woman;
- •The subject is diabetic;
- •The subject has a history of melanoma, squamous or basal cell carcinoma in the area of application of the lower back and hip;
- •The subject has any active skin disease which may contraindicate participation, including eczema, rash, broken or irritated skin, contact dermatitis and atopic dermatitis, or any skin condition that may be aggravated by heat;
- •The subject has used (within the previous week) or is using any topical drug or heatwrap or electrical heat pads at the application site; or
- •The subject has damaged skin in, or around the test sites which includes sunburn, uneven skin tones, tattoos, scars or other disfiguration at the application site, including an erythema grading of greater than 0 at the application site.
结局指标
主要结局
Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)
时间窗: Day 2 to Day 6
Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter \[cm\] diameter), bullae (\> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
次要结局
- Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)(Day 2 to Day 5)
- Time to First Significant Skin Event(Baseline to Day 6)
- Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)(Day 2 to Day 6)
- Time to First Report of Non-zero Erythema Score or Elevated Response(Baseline to Day 6)
- Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation(Baseline to Day 6)
- Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day(Baseline to Day 6)
- Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day(Baseline to Day 6)