Trial · NCT03698864
A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
NCT03698864, Phase 2, Completed, Processa Pharmaceuticals; results first posted 2022-10-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica. Trials, record NCT03698864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03698864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
- NCT number
- NCT03698864
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Processa Pharmaceuticals
- Conditions
- Necrobiosis Lipoidica
- Interventions
- PCS499
- First posted
- 2018-10-09
- Last updated
- 2026-10-22
- Results first posted
- 2022-10-03
- Limitations and caveats
- open label study
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 12 months | Number of Participants with Adverse Events/Serious Adverse Events (by type, severity, and relatedness) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of Patients With Adverse Events | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of Patients With Adverse Events | PCS499 900mg Twice a Day | 10 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PCS499 900mg Twice a Day | 12 | |
| Overall Study | COMPLETED | PCS499 900mg Twice a Day | 10 | |
| Overall Study | NOT COMPLETED | PCS499 900mg Twice a Day | 2 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | PCS499 900mg Twice a Day | 4 | 12 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Dry Mouth | Gastrointestinal disorders | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Influenza | Infections and infestations | PCS499 900mg Twice a Day | 2 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Ulcer | General disorders | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Abcess | Infections and infestations | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Gastroenteritis Viral | Infections and infestations | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Rash Pustular | Infections and infestations | PCS499 900mg Twice a Day | 1 | 12 | |
| other | Tooth Abcess | Infections and infestations | PCS499 900mg Twice a Day | 1 | 12 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PCS499 900mg Twice a Day | 0 | 12 |
| Total, other adverse events | PCS499 900mg Twice a Day | 10 | 12 |
| Total, serious adverse events | PCS499 900mg Twice a Day | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42054009 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03698864
GET https://conductscience.org/api/trials/v1/NCT03698864/events?page=2