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news.Provectus Pharmaceuticals has obtained approval to begin Phase II testing of PH-10, the company's topical drug for dermatology for the treatment of psoriasis.
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The study is designed to evaluate efficacy of PH-10 in a total of 25 subjects with moderate to severe forms of the disease and will be conducted at the Mount Sinai School of Medicine in New York City. In the study, PH-10 will be applied twice weekly for up to 12 weeks to each subject’s psoriatic plaque areas. Response will be observed throughout this treatment phase, and for one month after the end of this period.
Response will be graded using the psoriasis severity index and an investigator’s clinical assessment of plaque response. Changes in pruritus, time-to-response and preliminary assessment of durability of response will also be assessed, along with comprehensive safety monitoring.
Craig Dees, CEO of Provectus, said: “Building on the results from our Phase I program, which looked at safety and preliminary efficacy of several formulations of PH-10, we are pleased to begin this Phase II study in psoriasis. In addition to this study, we expect to soon begin clinical study of PH-10 for atopic dermatitis (eczema), and are continuing preclinical studies of PH-10 for treatment of infectious diseases of the skin, focused on antibiotic resistant Staphylococcus aureus, which is a growing public health concern.”