Study Summary
This trial will compare the effectiveness of a new drug, PCS499, to a placebo in treating ulcerations in patients with necrobiosis lipoidica (NL). 20 ulcerated NL patients will be enrolled and will be randomly assigned to receive either PCS499 or the placebo. The primary objective is to evaluate the efficacy of PCS499 as compared with placebo in ulcerated patients with NL.
- Necrobiosis Lipoidica
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: ~ 6 months
Trial Safety
Phase-Based Safety
Side Effects for
Trial Design
2 Treatment Groups
PCS499 900mg BID
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
4 Total Participants · 2 Treatment Groups
Primary Treatment: PCS499 · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 25.0% |
| North Carolina | 25.0% |
| Virginia | 25.0% |
| Other | 25.0% |
How old are they?
| 65+ | 33.3% |
| 18 - 65 | 66.7% |
What site did they apply to?
| Processa Clinical Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
Does my profile meet the criteria to be a participant in this trial?
"This clinical trial is recruiting 20 individuals diagnosed with necrobiosis lipoidica in the 18 to 80 year age range. To qualify, candidates must present at least one ulcer spanning a surface area of 1 cm2 on their reference leg and no more than six ulcers total, be willing to use contraception methods during their participation in the study, consume whole tablets as prescribed by investigators, and comply with all other study protocols." - Anonymous Online Contributor
What potential risks are associated with the administration of PCS499?
"Our team assesses the safety of PCS499 to be a 2, since Phase 2 testing has provided evidence of its security but not yet demonstrated its effectiveness." - Anonymous Online Contributor
Are there any vacancies open for entrants in this trial?
"Affirmative. Clinicaltrials.gov's information states that recruitment is open for this medical trial, which was posted on April 12th 2021 and subsequently edited in November 1st 2022. 20 individuals are to be admitted from 5 different centres of treatment." - Anonymous Online Contributor
How many facilities are presently administering this trial?
"This trial is presently recruiting patients from 5 distinct sites, including Milwaukee, San Diego and Philadelphia. To reduce travel-related stressors for participants, it is important to select the clinic closest you. Additionally, there are other locations available within this study's framework." - Anonymous Online Contributor
Is the age range for this experiment limited to those over fifty years of age?
"This research study is selecting individuals aged 18 and above, but under 80 years of age." - Anonymous Online Contributor
How many participants are included in this research project?
"Affirmative. Data accessible from clinicaltrials.gov verifies that this study is presently recruiting participants, having been initially posted on April 12th 2021 and last modified on November 1st 2022. This trial requires the recruitment of 20 patients across 5 different medical centres." - Anonymous Online Contributor