Topical 2% Simvastatin for Xanthelasma Palpebrarum

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Другое 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.

Первичные конечные точки

• Percentage Change in Index Lesion Area [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (6)

• Percentage Change in Index Lesion Longest Diameter [Срок оценки: Baseline to Week 24]
• Change in Index Lesion Height [Срок оценки: Baseline to Week 24]
• Investigator Global Aesthetic Improvement Scale [Срок оценки: Week 24]
• Change in Dermatology Life Quality Index [Срок оценки: Baseline to Week 24]
• Change in Patient Satisfaction With Lesion Appearance [Срок оценки: Baseline to Week 24]
• Patient Global Impression of Change [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07662785 · 020/Ethics-IRB-REC/CoLDS-UoGM/

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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