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Topical 2% Simvastatin for Xanthelasma Palpebrarum
NCT07662785Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2026
- Primary completion
- Aug 2027
- Sponsor
- Klira
- Conditions
- Xanthelasma palpebrarum (XP)
01
Overview
Phase 2, randomised, double-blind trial of simvastatin gel (Ain Shams University) in Xanthelasma palpebrarum (XP) (2 arms), sponsored by Klira. Primary endpoint: Percentage Change in Index Lesion Area at 24 weeks. Planned start Aug 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Topical Simvastatin 2% Cream
Topical simvastatin 2% cream applied once nightly.
Vehicle Cream
Vehicle cream applied once nightly during the double-blind phase, followed by topical simvastatin 2% cream during the open-label extension.
03
Who it enrols
Adults with a confirmed clinical diagnosis of xanthelasma palpebrarum and at least one measurable periocular lesion, excluding those with recent procedural or topical treatments to the area, active periocular inflammation, or unstable systemic lipid-lowering therapy.
04
Endpoints
Primary
Percentage Change in Index Lesion Area
Secondary
Percentage Change in Index Lesion Longest Diameter
Change in Index Lesion Height
Investigator Global Aesthetic Improvement Scale
Change in Dermatology Life Quality Index
Change in Patient Satisfaction With Lesion Appearance
Patient Global Impression of Change
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