Topical 2% Simvastatin for Xanthelasma Palpebrarum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Simvastatin 2% Cream, Vehicle cream.
- Who it may be relevant to
- Registry conditions: Xanthelasma Palpebrarum. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Clinical Trial of Topical 2% Simvastatin Versus Vehicle for Xanthelasma Palpebrarum
Overview
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.
Interventions
- Drug 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 - Other 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.
Primary outcome measures
- Percentage Change in Index Lesion Area [Time frame: Baseline to Week 24]
Secondary outcome measures (6)
- Percentage Change in Index Lesion Longest Diameter [Time frame: Baseline to Week 24]
- Change in Index Lesion Height [Time frame: Baseline to Week 24]
- Investigator Global Aesthetic Improvement Scale [Time frame: Week 24]
- Change in Dermatology Life Quality Index [Time frame: Baseline to Week 24]
- Change in Patient Satisfaction With Lesion Appearance [Time frame: Baseline to Week 24]
- Patient Global Impression of Change [Time frame: Week 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07662785 · 020/Ethics-IRB-REC/CoLDS-UoGM/