Provectus Pharmaceuticals, Inc. has begun phase 2 clinical testing of PH-10, the company's topical drug for dermatology, for the treatment of atopic dermatitis, a chronic skin condition that includes some forms of eczema. The study is designed to evaluate efficacy of PH-10 in a total of twenty subjects with mild to severe forms of the disease.
In the study, subjects will apply PH-10 daily for up to four weeks to their skin areas affected by atopic dermatitis. Response will be observed weekly throughout this treatment phase, and for one month after the end of this period. Response will be graded using the Investigator's Global Assessment (IGA) and Eczema Area Severity Index (EASI) assessment of response. Changes in pruritus (itching) will also be assessed, along with comprehensive safety monitoring. The study will be conducted at International Dermatology Research, Inc. of Miami, Florida.
"Building on the results from our phase 1 dermatology studies and early data from our current phase 2 in psoriasis, we are pleased to begin this important phase 2 study in atopic dermatitis," said Craig Dees, Ph.D., CEO of Provectus. "This study will allow us to assess both safety and efficacy of PH-10 for atopic dermatitis. The daily application of PH-10 in this study will also provide information relevant for treatment of other dermatologic conditions, such as psoriasis and infectious diseases of the skin, including antibiotic resistant Staphylococcus aureus (MRSA), which is a growing public health concern."
Dees continued, "These indications are largely underserved markets characterized by expensive, marginally-effective products that often carry a number of extremely undesirable side-effects. We are optimistic that PH-10 can improve the opportunities available to many of these patients."
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), about 15 million people in the United States have one or more symptoms of atopic dermatitis. It accounts for 15 to 20 per cent of all visits to dermatologists. The National Institutes of Health (NIH) estimates that atopic dermatitis costs US health insurance companies more than $1 billion every year.
Bernice R Krafchik, MBChB, FRCPC, Professor Emeritus, Department of Pediatrics, Section of Dermatology, University of Toronto has written on emedicine.com that the prevalence rate of atopic dermatitis internationally "is as high as 18% and is rising, especially in developed countries. In China and Iran, the prevalence rate is approximately 2-3%. The frequency is increased in patients who immigrate to developed countries from underdeveloped countries."
Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for moderate to severe psoriasis.