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

17 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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-jämförare: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage Change in Index Lesion Area
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage Change in Index Lesion Longest Diameter
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Klira Skin

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 september 2027

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 020/Ethics-IRB-REC/CoLDS-UoGM/

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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