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Topical 2% Simvastatin for Xanthelasma Palpebrarum (STAT-LID)

2026年6月17日 更新者：Klira Skin

A Randomized Clinical Trial of Topical 2% Simvastatin Versus Vehicle for Xanthelasma Palpebrarum

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Amber Khalil, MBChB
  • 电话号码：+447791731252
  • 邮箱：amberk@klira.skin

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Topical Simvastatin 2% Cream
Participants receive topical simvastatin 2% cream applied once nightly to xanthelasma lesions for 24 weeks during the double-blind phase. Participants then continue active treatment during the 24-week open-label extension.
药品：Topical Simvastatin 2% Cream
Topical simvastatin 2% formulated in a high-viscosity periocular-safe cream base. Participants apply the cream once nightly to xanthelasma lesions for 24 weeks during the randomized double-blind phase. One pump delivers approximately 0.25 mL, sufficient to cover the index lesion, with any remaining product applied to additional lesions. Participants are instructed to avoid the lash line and conjunctiva. Following completion of the blinded phase, all participants receive active treatment during a 24-week open-label extension.
安慰剂比较：Vehicle Cream
Participants receive an identical vehicle cream without active simvastatin applied once nightly for 24 weeks during the double-blind phase. Following completion of the blinded phase, participants receive topical simvastatin 2% cream during the 24-week open-label extension.
其他：Vehicle cream
Identical high-viscosity periocular-safe cream base without active simvastatin. Applied once nightly to xanthelasma lesions during the 24-week randomized double-blind phase. The vehicle is matched to active treatment in appearance, packaging, labelling, and application instructions to maintain study blinding. Participants subsequently receive active topical simvastatin 2% cream during the open-label extension phase.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage Change in Index Lesion Area
大体时间：Baseline to Week 24
Percentage change in the area (mm²) of the predefined index xanthelasma lesion from baseline to Week 24, assessed using calibrated digital planimetry on standardized clinical photographs.
Baseline to Week 24

次要结果测量

结果测量
措施说明
大体时间
Percentage Change in Index Lesion Longest Diameter
大体时间：Baseline to Week 24
Percentage change in the longest diameter (mm) of the predefined index xanthelasma lesion from baseline to Week 24, measured using standardized lesion measurements.
Baseline to Week 24
Change in Index Lesion Height
大体时间：Baseline to Week 24
Change in height (mm) of the predefined index xanthelasma lesion from baseline to Week 24, measured using standardized lesion measurements where measurable.
Baseline to Week 24
Investigator Global Aesthetic Improvement Scale
大体时间：Week 24
Investigator-assessed aesthetic improvement of the index xanthelasma lesion at Week 24 using the Investigator Global Aesthetic Improvement Scale, assessed on standardized clinical photographs by a blinded clinician.
Week 24
Change in Dermatology Life Quality Index
大体时间：Baseline to Week 24
Change in Dermatology Life Quality Index score from baseline to Week 24. The DLQI is a patient-reported dermatology-specific quality of life questionnaire scored from 0 to 30, with higher scores indicating greater impairment.
Baseline to Week 24
Change in Patient Satisfaction With Lesion Appearance
大体时间：Baseline to Week 24
Change in patient-reported satisfaction with the appearance of the eyelid lesion from baseline to Week 24, assessed using a 0 to 10 numerical rating scale, where 0 indicates not at all satisfied and 10 indicates completely satisfied.
Baseline to Week 24
Patient Global Impression of Change
大体时间：Week 24
Patient-reported global impression of change in the eyelid lesion at Week 24 compared with baseline, assessed using an ordinal response scale ranging from very much improved to very much worse.
Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Klira Skin

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月23日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 020/Ethics-IRB-REC/CoLDS-UoGM/

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

The study team is considering future sharing of de-identified individual participant data. Any data sharing would be subject to participant confidentiality, applicable data protection regulations, and appropriate governance procedures.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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