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.
2. PHONE CALL/TEXT
3. SCREENING VISIT
4. STUDY PARTICIPATION
- Do you have at least one open ulcer on your lower leg that is the size of a nickel?
- Are you willing to have blood drawn, swallow pills, and travel to the study clinic for visits?
- Have you been previously diagnosed with Necrobiosis Lipoidica?
- If YES, Have you had a recent biopsy within the past 5 years?
- If NO, Are you willing to have a biopsy to confirm diagnosis of your Necrobiosis Lipoidica?
- Are you between the age of 18 and 80 years old?
- Do you have up to 6 ulcers on your lower leg?
- Are you willing to come to the clinic for visits?
- Please list any medications you have taken in the past 6 weeks (including topical cream, prescription, and over the counter).
- Have you received any treatment with a biologic (e.g, adalimumab, etanercept, infliximab, anakinra, etc.) within the last 12 weeks?
- Have you received Phototherapy or photochemotherapy within the last 6 weeks?
- Within the last 6 weeks have you had a skin grafting or other surgical procedure?
- Do you have a history of any drug allergies, including but not limited to pentoxifylline or other xanthine derivatives, or other allergies?
- Do you currently have fever, or chronic, persistent, and recurring infection?
- Have you had any infection within the last 12 weeks that required oral or injected antibiotics, or hospitalization?
- Do you have a history of Sarcoidosis (tender red growths affecting the lungs / skin / lymph nodes) Or Pyoderma Gangrenosum (causes large, painful sores (ulcers) to develop on your skin)?
- Have you had any life-threatening infection or sepsis in the last 12 months?
- Have you had any significant cardiac disease in the last 6 months (e.g. angina or heart attack)?
- Do you have QT syndrome (a heart rhythm condition)?
- Within the last 6 months have you had any stroke, brain bleeding, gastrointestinal bleeding, or bleeding from the retina/ eye?
- Have you had any cancer or tumors in the past 5 years?
- Do you currently have a diagnosis of active tuberculosis within the last 3 months?
- Have you had a live vaccine within the last month?
- Have you participated in a clinical investigation within the last 30 days, or intend to participate in another clinical investigation during the course of this study?