Pilot Studies Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Difference in redness of Ultraviolet B induced erythema with 4% imipramine
研究概览
简要总结
Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.
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
- 是
入选标准
- •Fitzpatrick Skin Type I - IIII
- •Self-identified rosacea or no history of flushing/blushing for controls
- •Able to provide medical history and list of medications -- control subjects will not be allowed to take medications that are known to be photosensitizers.
排除标准
- •Using imipramine, amitriptyline or any other tricyclic antidepressant (oral or topical)
- •Using topical anti-inflammatory (within 1 week) or systemic agents (e.g. prednisone)
- •Large tattoos in the designated testing areas
- •Tanning bed use within last 3 months
- •Photodynamic Therapy or UCB treatments in past 3 months
- •Female Subjects: pregnant or nursing
研究组 & 干预措施
Imipramine and Vehicle
4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side.
干预措施: Imipramine (Drug)
Imipramine and Vehicle
4% imipramine and vehicle are applied on a 2x2cm2 area of the subject's cheek. The imipramine is applied on one side of the subject's face (cheek) and vehicle is applied on the other side.
干预措施: Vehicle (Drug)
Amitriptyline and Vehicle
4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side.
干预措施: Amitriptyline (Drug)
Amitriptyline and Vehicle
4% amitriptyline and vehicle are applied on a 2x2cm2 area of the subject's cheek. The amitriptyline is applied on side of the subject's face (cheek) and vehicle is applied on the other side.
干预措施: Vehicle (Drug)
结局指标
主要结局
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
时间窗: 24 hours post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
时间窗: 24 hours post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
时间窗: 10 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
时间窗: 60 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% imipramine
时间窗: 120 minutes post-treatment
Erythema change from baseline with 4% imipramine application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
时间窗: 10 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
时间窗: 60 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
Difference in redness of Ultraviolet B induced erythema with 4% amitriptyline
时间窗: 120 minutes post-treatment
Erythema change from baseline with 4% amitriptyline application in response to a low level of UVB are measured by using a mexameter device and thermal photography.
次要结局
- Tolerability of 4% imipramine on facial skin(24 hours post-treatment)
- Tolerability of 4% amitriptyline on facial skin(24 hours post-treatment)
- Tolerability of 4% imipramine on facial skin(10 minutes post-treatment)
- Tolerability of 4% imipramine on facial skin(60 minutes post-treatment)
- Tolerability of 4% imipramine on facial skin(120 minutes post-treatment)
- Tolerability of 4% amitriptyline on facial skin(10 minutes post-treatment)
- Tolerability of 4% amitriptyline on facial skin(60 minutes post-treatment)
- Tolerability of 4% amitriptyline on facial skin(120 minutes post-treatment)