Here, we describe the first report of clinical translation of CAGE from the lab into the clinic for the treatment of rosacea, a common chronic inflammatory skin disorder that affects the face. We describe the seven steps of clinical translation including (a) scale-up, (b) characterization, (c) stability analysis, (d) mechanism of action, (e) dose determination, (f) GLP toxicity study, and
(g) human clinical study.
Herein, we describe a skin protectant, IonLASTTM, based on an ionic liquid/deep eutectic solvent, formed by GRAS materials, choline and geranic acid (CAGE, CG-101), that provides protection for at least 4h after a single application. IonLASTTM was formulated as a gel that facilitates easy application on the skin. Tolerance of CG-101 was substantiated through a study in human volunteers. In vitro studies confirmed that IonLASTTM effectively inactivates a human coronavirus hCoV229E. A second human clinical study established that a single application of IonLASTTM imparts protection against microbes that lasts up to several hours.
The limitations of topical nucleic acid delivery were circumvented by using an ionic liquid (IL) combination to successfully deliver a small interfering RNA (siRNA)-based treatment directly to the skin in a mouse model of psoriasis, significantly reducing levels of inflammatory cytokines and symptoms of psoriasis without systemic side effects.