Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin: an Open-label Within-subject Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in frequency of skin tears.
研究概览
简要总结
The purpose of this research is to determine whether once nightly application of tretinoin 0.1% cream to forearm skin reduces the frequency of skin tears and bruising (solar purpura), and changes skin thickness over a period of 6 months.
详细描述
Easy bruising and tearing of forearm skin is common with aging and can cause activity restriction, infection, and pain. Chronic exposure to UV light from the sun causes skin thinning and loss of supportive collagen over time. Thin skin tears easily and blood vessels normally protected by collagen rupture, causing bruises. Tretinoin is a prescription vitamin A cream that has been shown to increase skin thickness and collagen. Tretinoin is FDA approved for treatment of acne. We are trying to figure out if putting tretinoin cream on the forearms of adults with thin skin prevents skin tears and bruising.
We are looking for 30 people with a history of skin tears in the United States. The VA Palo Alto expects to enroll 30 research study subjects.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (55+)
- •History of skin tears, at least 2 in the past month
- •History of skin bruising (solar purpura)
- •Ambulatory
- •Able to apply topical medication to oneself
排除标准
- •<55 years old)
- •Pregnant or breastfeeding
- •History of allergy to tretinoin
- •History of atopic dermatitis, psoriasis, bullous skin disease, cutaneous lupus, or cutaneous T cell lymphoma.
- •Planned cutaneous surgery on either forearm in the next 6 months
- •Use of any topical medication on the forearms within past month
- •Current or anticipated phototherapy of the forearms in the next 6 months
- •Current or anticipated chemotherapy within the next 6 months
- •Use of oral steroids within past month
- •Current or prior isotretinoin therapy within past 6 months
- •AV fistula of the arm
研究组 & 干预措施
Arm participants apply tretinoin (LEFT or RIGHT)
Participants will apply tretinoin 0.1% cream nightly for 6 months.
干预措施: Tretinoin 0.1% cream (Drug)
Arm participants apply tretinoin (LEFT or RIGHT)
Participants will apply tretinoin 0.1% cream nightly for 6 months.
干预措施: Bland cream (non-drug) (Drug)
Arm participants apply bland cream (not treatment) (LEFT or RIGHT)
Participants apply bland cream to the other arm nightly as a placebo.
干预措施: Bland cream (non-drug) (Drug)
结局指标
主要结局
Change in frequency of skin tears.
时间窗: 6 months.
Change in epidermal (top layer of skin) thickness.
时间窗: 6 months.
次要结局
- Change in percent of skin on the arms involved by solar purpura (bruising).(6 months.)
研究者
James Thomas Pathoulas
Investigator
Stanford University