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The topical gel vehicle is the placebo control used in clinical trials for SB204 (berdazimer sodium), an investigational nitric oxide-releasing topical treatment for acne vulgaris developed by Novan, Inc. This vehicle formulation is a dual-phase gel designed to be physically and chemically identical to the active SB204 drug product, excluding the active pharmaceutical ingredient NVN1000. It is administered topically as a dual-component system, where the vehicle gel is mixed with a pH-buffered hydrogel at the time of application to mimic the delivery mechanism used to trigger nitric oxide release in the active treatment arm. The vehicle was utilized in Phase 3 clinical trials to provide a comparative baseline for evaluating the reduction of inflammatory and non-inflammatory lesions in patients with acne vulgaris.
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