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Excipial hydrocream is a moisturizing topical base used as the inactive vehicle (placebo) in the TOPICAL phase 2 clinical trial (NCT03972592). Sponsored by University Hospital, Tours, the trial evaluates the efficacy of 0.1% topical sirolimus against this vehicle in a split-body design for patients with cutaneous microcystic lymphatic malformations (CMLMs). The vehicle is an oil-in-water emulsion designed to be indistinguishable from the active sirolimus cream, providing a control for the physical effects of cream application and the natural history of the disease over the 12-week treatment period. As a vehicle, it lacks the active pharmaceutical ingredient (sirolimus) and is used to assess the baseline effect of the cream formulation and the natural progression of the malformation during the study.
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