What is Necrobiosis Lipoidica
Necrobiosis Lipoidica (NL) is a chronic skin condition with no currently approved U.S. Food and Drug Administration (FDA) treatment. NL is more common in individuals with diabetes and women, with an average age of onset between 20 and 60 years. Some people are at more risk of developing NL, including Type 1 and Type 2 diabetics as well as those who smoke. People with Necrobiosis Lipoidica experience a persistent skin condition that develops into ulcerated lesions in about one-third of cases. Ulceration can cause severe complications, such as life-threatening infections and necrosis (necrosis is the death of body tissue that occurs when too little blood flows to the tissue).
Necrobiosis Lipoidica is an inflammatory condition in which shiny, red-brown or yellowish patches develop in the skin. Patches of NL usually start as one or more small, red, slightly raised areas on front side of one or both lower legs (below knee). Much less often, similar areas may develop on other parts of the legs, and even on the hands, arms, trunk or face. These lesions grow slowly and may join up to form larger, flatter, irregularly shaped areas, usually with a well-defined, red border and a shiny, yellowish center, with visible blood vessels. These patches tend to be persistent. As the skin is thin in these areas, it is prone to breakdown (split) forming ulcers (whereby a layer of dead tissue becomes separated from the surrounding living tissue) with minor injury to the skin. These ulcerated areas can also get infected.
This study will focus on treating the ulcers related to your NL.
Do you have open ulcers due to your NL?
About the Study
Processa Pharmaceuticals has initiated a randomized, double blind, placebo controlled study that will evaluate the efficacy and safety of PCS499 (an investigational oral medication from Processa Pharmaceuticals) as compared to placebo for the treatment of ulcerations of patients with Necrobiosis Lipoidica (NL). Approximately 20 patients with ulcers due to their NL who also meet other inclusion/exclusion criteria will be enrolled in the study.
There is NO COST to you to participate in the trial. Processa Pharmaceuticals will cover travel costs (air, train, hotel, etc) for patient’s needing to travel to clinical sites.
Necrobiosis Lipoidica FAQs
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Who sponsored this trial?
Processa Pharmaceuticals is the sponsor of this clinical trial. The mission of Processa Pharmaceuticals is to develop products for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life.