NCT03698864

A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

An Open-Label Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Processa Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study that will evaluate the safety of PCS499 for the treatment of necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 12 NL patients (6-9 patients without ulceration and 3-6 patients with ulceration) who also meet other inclusion/exclusion criteria will be enrolled in the study. The primary objective of this study is to evaluate the safety and tolerability profile of PCS499 in patients with Necrobiosis Lipoidica.

Conditions

• Necrobiosis Lipoidica

Interventions

Type	Name	Description
DRUG	PCS499	PCS499 900mg twice a day with food

Timeline

• Start date: 2018-11-07
• Primary completion: 2020-02-25
• Completion: 2020-02-25
• First posted: 2018-10-09
• Last updated: 2022-10-03
• Results posted: 2022-10-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study