Topical 2% Simvastatin for Xanthelasma Palpebrarum (STAT-LID)
17 de junio de 2026 actualizado por: Klira Skin
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Amber Khalil, MBChB
- Número de teléfono: +447791731252
- Correo electrónico: amberk@klira.skin
Copia de seguridad de contactos de estudio
- Nombre: Emma Craythorne, MBChB FRCP
- Correo electrónico: dremmac@klira.skin
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador de placebos: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage Change in Index Lesion Area
Periodo de tiempo: 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.
|
Baseline to Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage Change in Index Lesion Longest Diameter
Periodo de tiempo: 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.
|
Baseline to Week 24
|
|
Change in Index Lesion Height
Periodo de tiempo: 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.
|
Baseline to Week 24
|
|
Investigator Global Aesthetic Improvement Scale
Periodo de tiempo: 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.
|
Week 24
|
|
Change in Dermatology Life Quality Index
Periodo de tiempo: 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.
|
Baseline to Week 24
|
|
Change in Patient Satisfaction With Lesion Appearance
Periodo de tiempo: 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.
|
Baseline to Week 24
|
|
Patient Global Impression of Change
Periodo de tiempo: 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.
|
Week 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 020/Ethics-IRB-REC/CoLDS-UoGM/
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .