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Topical 2% Simvastatin for Xanthelasma Palpebrarum

Study acronym: STAT-LID
StatusNot Yet Recruiting
PhasePhase 2
SponsorKlira Skin
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07662785
Lead Sponsor Klira Skin
Conditions
(from sponsor)
Xanthelasma Palpebrarum
Related terms Xanthomatosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov