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PCS499 for Necrobiosis Lipoidica

Phase 2
Waitlist Available
Research Sponsored by Processa Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~ 6 months
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~ 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~ 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of ulcer closure as assessed by skin exam in patients treated with PCS499 as compared to placebo

Side effects data

From 2020 Phase 2 trial • 12 Patients • NCT03698864
33%
Nausea
17%
Influenza
8%
Dizziness
8%
Tooth Abcess
8%
Blood Glucose Increased
8%
Skin Papilloma
8%
Abcess
8%
Upper Respiratory Tract Infection
8%
Dry Mouth
8%
Eschar
8%
Decreased Appetite
8%
Rash Pustular
8%
Abdominal Discomfort
8%
Electrocardiogram Qt Prolonged
8%
Gastroenteritis Viral
8%
Anaemia
8%
Hyperkalaemia
8%
Migraine
8%
Proteinuria
8%
Alopecia
8%
Ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
PCS499 900mg Twice a Day

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PCS499 900mg BIDExperimental Treatment1 Intervention
PCS499 900mg twice a day with food
Group II: PlaceboPlacebo Group1 Intervention
similar in appearance to active study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCS499
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Virginia
Other
How old are they?
65+
18 - 65
What site did they apply to?
Processa Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
2021. "A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800562.
~1 spots leftby Apr 2025
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