Contact a Trial Coordinator for more information on our trials.
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
Actual Start Date
April 12, 2021
Actual Primary Completion Date
August 1, 2022
This is a randomized, double blind, placebo controlled study that will evaluate the efficacy and safety of PCS499 as compared to placebo for the treatment of ulcerations of patients with necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 20 ulcerated NL patients who also meet other inclusion/exclusion criteria will be enrolled in the study. The primary objective of this study is to evaluate the efficacy of PCS499 as compared with placebo in ulcerated patients with Necrobiosis Lipoidica.
- PCS499 900mg twice a day with food
- placebo comparator
Actual Study Completion Date
December 1, 2022
The following cities have PCS499 clinical trial sites. Please check back often as locations will be updated.
About Necrobiosis Lipoidica
Necrobiosis lipoidica (NL) is a chronic, disfiguring condition affecting the skin and tissue under the skin typically on the lower extremities with no currently approved FDA treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis threatening life of the limb.
Approximately 74,000 - 185,000 people in the United States and more than 200,000 – 500,000 people outside the United States are affected by NL with the prevalence of open ulcers being approximately 30% of all NL patients.
The degeneration of tissue occurring at the NL lesion site is caused by a number of pathophysiological changes which has made it extremely difficult to develop effective treatments for this condition. At this time there is no approved FDA treatment for NL and PCS499 could be the first drug approved. PCS499 and its metabolites affect a number of biological pathways, several of which contribute to the pathophysiology associated with NL.
The safety and efficacy of the investigational use of this product have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.