A Randomized Clinical Trial of Topical 2% Simvastatin Versus Vehicle for Xanthelasma Palpebrarum
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
This study is evaluating whether a topical cream containing 2% simvastatin can improve xanthelasma palpebrarum, a common condition that causes yellow cholesterol deposits on the eyelids. Current treatments such as surgery, laser therapy, and chemical treatments can be effective but may cause scarring, pigment changes, or recurrence.
In this randomized, double-blind, vehicle-controlled trial, 30 adults with xanthelasma will be assigned to receive either topical 2% simvastatin cream or an identical inactive vehicle cream for 24 weeks. Neither participants nor investigators will know which treatment is being used during this period. After 24 weeks, all participants will receive active simvastatin treatment for an additional 24 weeks in an open-label extension.
The study will assess changes in lesion size and appearance using standardized photography and measurements, as well as patient satisfaction, quality of life, and treatment tolerability. Results from this pilot study will help determine whether topical simvastatin may be a safe and effective non-invasive treatment option for xanthelasma and inform the design of larger future studies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years or older
- •Clinical diagnosis of xanthelasma palpebrarum confirmed by a study investigator
- •At least one measurable periocular xanthelasma lesion
- •No procedural treatment to the study lesion(s) within the past 3 months, including excision, laser, cryotherapy, chemical cautery/trichloroacetic acid, electrocautery, or radiofrequency
- •Capacity to provide informed consent
- •Willingness to avoid other treatments for xanthelasma during the study
排除标准
- •Known allergy or sensitivity to any study cream ingredient
- •Active periocular inflammatory disease
- •Use of topical eyelid treatments within the past 4 weeks, including topical corticosteroids, retinoids, acid peels, depigmenting agents, compounded creams, or over-the-counter eye creams containing active ingredients
- •Pregnancy or breastfeeding
- •Participation in another interventional clinical trial
- •Current unstable systemic lipid-lowering therapy
- •Initiation of, or dose change to, oral statin therapy within the past 8 weeks
- •Any condition judged by the investigator to make participation unsafe