NCT04800562

A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Processa Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Necrobiosis Lipoidica

Interventions

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

Timeline

• Start date: 2021-04-12
• Primary completion: 2023-02-28
• Completion: 2023-04-14
• First posted: 2021-03-16
• Last updated: 2023-08-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study