Trials Sponsors Conditions Drugs Pricing

Conditions

Necrobiosis Lipoidica

Outcome Measures

Primary Outcomes (1)

Incidence of ulcer closure as assessed by skin exam in patients treated with PCS499 as compared to placebo
Evaluation of proportion of patients with wound closure based on skin evaluation in patients with NL as compared with placebo
~ 6 months

Study Arms (2)

PCS499 900mg BID

EXPERIMENTAL

PCS499 900mg twice a day with food

Drug: PCS499

Placebo

PLACEBO COMPARATOR

similar in appearance to active study drug

Other: placebo

Interventions

PCS499Drug

PCS499 900mg twice a day with food

PCS499 900mg BID

placeboOther

placebo comparator

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients age 18 to 80 years of age, inclusive, at Screening.
Biopsy-confirmed diagnosis of NL. Biopsies of continually active lesions performed outside of this clinical study will need to be reviewed and the diagnosis confirmed by the study pathologist. For patients with no previous history of biopsy, no biopsy within the previous 5 years, a biopsy that is not confirmed to be NL, or newly active lesion, a biopsy to confirm a diagnosis of NL will be performed at the Screening visit.

Sponsors & Collaborators

Processa Pharmaceuticals
Industrylead

Study Sites (4)

Processa Clinical Site

San Diego, California, 92123, United States

Processa Clinical Site

Rochester, Minnesota, 55905, United States

Processa Clinical Site

Charleston, South Carolina, 29407, United States

Processa Clinical Site

Milwaukee, Wisconsin, 53266, United States

MeSH Terms

Conditions

Necrobiosis Lipoidica

Condition Hierarchy (Ancestors)

Necrobiotic DisordersCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesSkin Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Sian Bigora, PharmD
Processa Pharmaceuticals
STUDY DIRECTOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 16, 2021

Study Start

April 12, 2021

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PCS499 900mg BID

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

PCS499 900mg BID

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations