Topical 2% Simvastatin for Xanthelasma Palpebrarum

Starting soon · Phase 2

Conditions studied: Xanthelasma Palpebrarum

In brief

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.

Key facts

Study ID

NCT07662785

Run by

Klira Skin

People needed

30

Starts

2026-08-01

Expected to finish

2027-09-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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