vehicle pre foam formulation-LEO Pharma-rosacea

The vehicle pre foam formulation is a topical placebo control developed by LEO Pharma for use in clinical trials evaluating Finacea (azelaic acid) Foam, 15%. This formulation contains the same inactive ingredients as the active product—including benzoic acid, cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and xanthan gum—but lacks the active therapeutic agent, azelaic acid. It was specifically utilized as a comparator in randomized, double-blind, Phase 1 dermal safety studies, such as Human Repeated Insult Patch Test (HRIPT) designs, to assess the sensitization potential and overall safety profile of the foam delivery system in healthy subjects. The active counterpart is indicated for the treatment of inflammatory papules and pustules associated with mild to moderate rosacea.

Other names

Vehicle pre foam formulationFinacea Foam Vehicle