At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
PCS499drug
Likely dose
PCS499 900mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
In Brief
A Phase 2 clinical trial evaluating PCS499 for Necrobiosis Lipoidica. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNecrobiosis Lipoidica
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedOct 9, 2018
Enrollment StartNov 7, 2018
Primary CompletionFeb 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.7 years ago
Interventions
PCS499drug
PCS499 900mg twice a day with food