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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Xanthelasma Palpebrarum
• Intervention / Treatment: Drug: Topical Simvastatin 2% Cream; Other: Vehicle cream

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amber Khalil, MBChB; Phone Number: +447791731252; Email: amberk@klira.skin
• Study Contact Backup: Name: Emma Craythorne, MBChB FRCP; Email: dremmac@klira.skin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 24-week open-label extension.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Index Lesion Area	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Index Lesion Longest Diameter	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Klira Skin

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Simvastatin; Statin; Double Blind Trial; Xanthelasma Palpebrarum; Xanthelasma; Topical Simvastatin; Topical Statin; Periocular Xanthoma; Eyelid Xanthoma; Cosmetic Dermatology
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Xanthomatosis; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Lovastatin; Simvastatin
• Other Study ID Numbers: 020/Ethics-IRB-REC/CoLDS-UoGM/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No