Trials Sponsors Conditions Drugs Pricing

Conditions

Necrobiosis Lipoidica

Outcome Measures

Primary Outcomes (1)

Number of Participants With Adverse Events
Number of Participants with Adverse Events/Serious Adverse Events (by type, severity, and relatedness)
12 months

Study Arms (1)

PCS499 900mg twice a day

EXPERIMENTAL

deuterated pentoxifylline analog dosed twice a day at 900 mg

Drug: PCS499

Interventions

PCS499Drug

PCS499 900mg twice a day with food

Also known as: deuterated pentoxifylline analog

PCS499 900mg twice a day

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 (2)

Processa Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Processa Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Related Publications (1)

Rubenstein AI, Das M, Nyberg M, Bigora S, Young D, Kim E, Ferris L, Rosenbach M. Deuterated Pentoxifylline Analog in the Treatment of Necrobiosis Lipoidica: A Nonrandomized Clinical Trial. JAMA Dermatol. 2026 Jun 1;162(6):613-618. doi: 10.1001/jamadermatol.2026.0863.
PMID: 42054009DERIVED

MeSH Terms

Conditions

Necrobiosis Lipoidica

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

open label study

Results Point of Contact

Title: Mary G. Nyberg, VP Clinical Operations
Organization: Processa Pharmaceuticals

Study Officials

Maya Das, MD
Processa Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 9, 2018

Study Start

November 7, 2018

Actual (reported)

You may not qualify if:

Current or previous (within 4 weeks of Baseline) treatment with:
Oral, topical, or intralesional corticosteroids;
Systemic pentoxifylline, theophylline, or cilostazol
Oral or topical retinoid;
Other systemic or topical immunosuppressant drugs, including but not limited to calcineurin inhibitors (e.g., tacrolimus), thalidomide, apremilast, anti-malarials (e.g., hydroxychloroquine, chloroquine), cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, etc.
Current or previous (within 12 weeks of Baseline) treatment with any biologic therapy (e.g., adalimumab, etanercept, infliximab, anakinra, etc.).
Phototherapy/photochemotherapy (Narrow band ultraviolet B, Ultraviolet B, Psoralen + ultraviolet A) within 6 weeks prior to Baseline
Skin grafting, or other surgical procedure (other than debridement) within 6 weeks prior to Baseline.
History of drug allergy, including but not limited to pentoxifylline or other xanthine derivatives, or other allergy, which in the opinion of the Investigator, contraindicates participation.
Anticipated concurrent use of a strong CYP1A2 inhibiting drug, including but not limited to cimetidine and/or fluvoxamine, during the course of the study (after Screening).
Fever (\>38°C), or chronic, persistent, or recurring infection(s) at Screening or Baseline.
Any infection requiring oral antimicrobial therapy within 2 weeks prior to Baseline or any infection requiring parenteral antibiotics or hospitalization within 12 weeks prior to Baseline. Any treatment for such infections must have been completed and the infection cured for at least 2 weeks prior to Baseline.
History of sarcoidosis, pyoderma gangrenosum, or any other disorder (in the judgment of the Investigator) that would interfere with the evaluation of NL or require protocol prohibited medication.
History of any life threatening infection or sepsis within 12 months of Baseline:
Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of Baseline, and arrhythmia requiring therapy.
+22 more criteria

A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

PCS499 900mg twice a day

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

PCS499 900mg twice a day

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations