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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Simvastatin 2% Cream | Experimental | 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. |
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| Vehicle Cream | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Simvastatin 2% Cream | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber Khalil, MBChB | Contact | +447791731252 | amberk@klira.skin | |
| Emma Craythorne, MBChB FRCP | Contact | dremmac@klira.skin |
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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.
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| ID | Term |
|---|---|
| D014973 | Xanthomatosis |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Vehicle cream | Other | 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. |
|
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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |