Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in dermatologic score
研究概览
简要总结
This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea
详细描述
The duration of the study will be 22 days. Subjects will use a cream with a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor on one cheek, and a cream lacking the inhibitor (vehicle control) on the other. Patients will receive a randomized set of creams for the right and left cheek, one containing the active ingredient. Subjects will be evaluated on days 1, 8, 15 and 22. Skin appearance will be scored in each visit. A blood sample will be obtained to determine the levels of systemic drug absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation of drug to cheek side for each bottle set is known only to an investigator not involved in patient assessment and will be unmasked only at the end of the trial.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Erythematotelangiectatic rosacea diagnosed by a clinician in the centrofacial and/or ocular regions.
排除标准
- •Other concurrent diseases for which treatment is being received that would preclude the use of trametinib (i.e., pleural effusion, active infection, intracranial bleeding)
- •History of skin allergic reactions or documented allergic reaction to trametinib
- •Pregnancy or lactation.
- •Heart failure or other heart disease
- •Active use of medications with known documented interactions with trametinib (Chloroquine, Ritonavir, Loperamide, Penicillamine)
研究组 & 干预措施
Trametinib
Cheek describing the active compound (topical cream containing 0.1 mg/g trametinib)
干预措施: Trametinib (Drug)
Vehicle
Cheek receiving cream without active compound (topical cream lacking active ingredient)
干预措施: Trametinib (Drug)
结局指标
主要结局
Change in dermatologic score
时间窗: 22 days
Weekly assessment of skin irritation, using the Organization for Economic Cooperation and Development test for dermal irritation and corrosion. This test measures cutaneous erythema and edema separately on scales that range from 0 (absence of erythema or edema) to 4 (severe), with higher scores representing worse outcomes.
次要结局
- Systemic drug absorption(22 days)