Xanthelasma Palpebrarum
Conditions
Keywords
Xanthelasma Palpebrarum, Xanthelasma, Topical Simvastatin, Simvastatin, Topical Statin, Statin, Periocular Xanthoma, Eyelid Xanthoma, Randomized Controlled Trial, Double Blind Trial, Cosmetic Dermatology
Brief summary
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
DRUGTopical 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.
OTHERVehicle 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.
Sponsors
Klira Skin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Index Lesion Area | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Index Lesion Longest Diameter | 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. |
| Change in Index Lesion Height | 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. |
| Investigator Global Aesthetic Improvement Scale | 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. |
| Change in Dermatology Life Quality Index | 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. |
| Change in Patient Satisfaction With Lesion Appearance | 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. |
| Patient Global Impression of Change | 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. |
Contacts
CONTACTAmber Khalil, MBChB
CONTACTEmma Craythorne, MBChB FRCP
Outcome results
None listed