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

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.

Timeline

Start

2018-11-07

Primary completion

2020-02-25

Completion

2020-02-25

Publications

• Rubenstein AI, Das M, Nyberg M, Bigora S, Young D, Kim E, Ferris L, Rosenbach M. Deuterated Pentoxifylline Analog in the Treatment of Necrobiosis Lipoidica: A Nonrandomized Clinical Trial. JAMA Dermatol. 2026 Jun 1;162(6):613-618. doi: 10.1001/jamadermatol.2026.0863.

Drugs

Indications