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NCT04800562 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Processa Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT04800562: Clinical Trial Phase 2 study, sponsored by Processa Pharmaceuticals.

NCT04800562 is a Phase 2 study that was terminated before completion, run by Processa Pharmaceuticals. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04800562, a Phase 2 study, was terminated before completion, sponsored by Processa Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study 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.

Primary Outcome

Evaluation of proportion of patients with wound closure based on skin evaluation in patients with NL as compared with placebo

Interventions

  • OTHER placebo
  • DRUG PCS499

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2021-04-12
Est. Completion 2023-04-14
Phase Phase 2
Processa Pharmaceuticals

9 total trials

Why NCT04800562 stopped before completion

NCT04800562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT04800562 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04800562 about?

NCT04800562 is a clinical study titled "A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica". 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 w...

What is the current status of trial NCT04800562?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-04-12. Estimated completion is 2023-04-14.

What interventions are being tested in trial NCT04800562?

The interventions under investigation include: placebo (OTHER), PCS499 (DRUG).

Who is sponsoring clinical trial NCT04800562?

This trial is sponsored by Processa Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04800562's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04800562, the US trial registry maintained by the National Library of Medicine. NCT04800562 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.