Formulation 00B

Formulation 00B is a topical cutaneous emulsion developed by ISDIN to serve as the vehicle control (placebo) in clinical trials evaluating experimental topical formulations of ciclosporin. Specifically, it was used as the comparator for Formulation 01B (0.5% ciclosporin) and Formulation 02B (1.5% ciclosporin) in a Phase I, randomized, vehicle-controlled study for the treatment of psoriasis vulgaris. As a vehicle, it is designed to match the physical and chemical properties of the active formulations—including the emulsion base and excipients—but lacks the active pharmaceutical ingredient, ciclosporin. This allows for the assessment of the baseline effect of the formulation base and ensures the integrity of double-blinded psoriasis plaque tests.

Other names

Vehicle to Formulation 01B and Formulation 02BVehicle of topical ciclosporin emulsion