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This gel base is the inactive vehicle control used by LEO Pharma in clinical development, specifically within a Phase 2 multicenter pilot study (NCT00408330) evaluating the treatment of mild to moderate facial seborrheic dermatitis. It is a topical formulation designed to be pharmacologically inert, serving as the placebo comparator for azelaic acid 15% gel. The vehicle contains a specific mixture of excipients including benzoic acid as a preservative, disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide for pH adjustment. By utilizing this identical vehicle without the active azelaic acid component, researchers can isolate the therapeutic efficacy and safety profile of the active drug in dermatological conditions.
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