PCS499 for Necrobiosis Lipoidica

Processa Clinical Site, Kyiv, Ukraine
Necrobiosis LipoidicaPCS499 - Drug
18 - 80
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Necrobiosis Lipoidica

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: ~ 6 months

~ 6 months
Incidence of ulcer closure as assessed by skin exam in patients treated with PCS499 as compared to placebo

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

PCS499 900mg Twice a Day
8%Blood Glucose Increased
8%Decreased Appetite
8%Upper Respiratory Tract Infection
8%Skin Papilloma
8%Electrocardiogram Qt Prolonged
8%Abdominal Discomfort
8%Dry Mouth
8%Gastroenteritis Viral
8%Rash Pustular
8%Tooth Abcess
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03698864) in the PCS499 900mg Twice a Day ARM group. Side effects include: Nausea with 33%, Influenza with 17%, Blood Glucose Increased with 8%, Dizziness with 8%, Decreased Appetite with 8%.

Trial Design

2 Treatment Groups

PCS499 900mg BID
1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

4 Total Participants · 2 Treatment Groups

Primary Treatment: PCS499 · Has Placebo Group · Phase 2

PCS499 900mg BID
Experimental Group · 1 Intervention: PCS499 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: ~ 6 months

Who is running the clinical trial?

Processa PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
131 Total Patients Enrolled
1 Trials studying Necrobiosis Lipoidica
12 Patients Enrolled for Necrobiosis Lipoidica
Sian Bigora, PharmDStudy DirectorProcessa Pharmaceuticals

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?
North Carolina25.0%
How old are they?
18 - 6566.7%
What site did they apply to?
Processa Clinical Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.