Necrobiosis LipoidicaPhase 2NCT03698864

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

A Phase 2 study testing PCS499 in people with Necrobiosis Lipoidica, run by Processa Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label study that will evaluate the safety of PCS499 for the treatment of necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 12 NL patients (6-9 patients without ulceration and 3-6 patients with ulceration) who also meet other inclusion/exclusion criteria will be… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Necrobiosis Lipoidica
What is being tested?: PCS499
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesUnited States
Study dates: 7 Nov 2018to 25 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Reference NL lesion with a score of 2 or greater on the Investigator Global Assessment: Necrobiosis Lipoidica (IGA:NL) Activity scale AND surface area with minimum size of 10 cm2. If more than one lesion is present, the reference lesion area is the lesion with the highest disease severity.
Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Baseline before dosing.
Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study: oral contraceptive medication, intrauterine device (IUD), hormonal implants, injectable contraceptive medications, double-barrier methods, or tubal ligation.
Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and increased follicle-stimulating hormone (FSH) > 40 milli-International Unit (mIU)/mL. If necessary to confirm postmenopausal status, an FSH will be drawn at Screening) or who have undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing.

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Male patients must be willing to use appropriate contraceptive measures and refrain from sexual activity with any female who is pregnant or lactating.
Patient must be willing and able to swallow whole tablets.
Patient must be willing and able to comply with study procedures.
Patient must be willing and able to provide signed, informed consent.

Who cannot join

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.).

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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.
Patient has corrected QT interval (QTc) interval ≥ 480 milliseconds on Screening Electrocardiogram (ECG); a second Screening ECG may be done at investigator's discretion but the average of the two QTc screening intervals must not be ≥ 480 milliseconds.History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of Baseline.
History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of Baseline.
Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma or carcinoma in situ of the cervix) within the past 5 years prior to Baseline.
Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and/or any other clinically significant disease or disorder, which in the opinion of the Investigator (by its nature or by being inadequately controlled), may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.
History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration >= 5 millimeter (mm), or a positive QuantiFERON-TB test or positive or borderline T-Spot [Elispot] test); or positive TB test at Screening. Subjects with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.
Vaccination with live or live-attenuated virus vaccine within 1 month prior to Baseline.
The results of the following laboratory tests performed at the central laboratory at Screening meet any of the criteria below:
Hemoglobin < 8.0 g/dL (International System of Units (SI): < 80 g/L);
White blood cells < 3.0 x 10^3 cells/mm^3 (SI: < 3.0 x 10^9 cells/L);
Neutrophils < 1.0 x 10^3 cells/mm^3 (SI: < 1.0 x 10^9 cells/L);
Lymphocytes < 0.5 x 10^3 cells/mm^3 (SI: < 0.5 x 10^9 cells/L);
Platelets < 100 x 10^3 cells/mm^3 (SI: < 100 x 10^9 cells/L)
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) ≥ 2 x upper limit of normal (ULN);
Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented;
Estimated glomerular filtration rate < 40 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) formula.
Positive HIV serology
Evidence of active Hepatitis B Virus (HBV) infection
Evidence of active Hepatitis C Virus (HCV) infection
Women who are pregnant or breastfeeding.
Patient unwilling or unable to swallow tablets whole.
Any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
Use of any investigational product within 30 days prior to Baseline or currently enrolled in another study that involves clinical investigations.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Processa Investigational Site
Philadelphia, Pennsylvania, 19104
Processa Investigational Site
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: An Open-Label Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

Read the detailed description

This is an open-label study to evaluate the safety of PCS499 for the treatment of necrobiosis lipoidica (NL) and will inform the design of future studies. The primary objective of this study is to evaluate the safety and tolerability profile of two doses of PCS499 in patients with Necrobiosis Lipoidica.

Conditions: Necrobiosis Lipoidica
Being tested: PCS499
Medical subject headings: Necrobiosis Lipoidica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCS499Drug
Also called deuterated pentoxifylline analog
PCS499 900mg twice a day with food

Study groups in NCT03698864
Study group	Role	What they receive
PCS499 900mg twice a day	Experimental	deuterated pentoxifylline analog dosed twice a day at 900 mg Receives: Drug: PCS499

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 201825 Feb 2020

First posted9 Oct 2018
Study start7 Nov 2018
Primary completion25 Feb 2020
Study completion25 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Necrobiosis LipoidicaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03698864
Sponsor's protocol ID: PCS499-NL01
Status last verified: Oct 2026
First submitted: 1 Oct 2018
Last updated: 22 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 42054009

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
ClinicalTrials.gov ID: NCT03698864
Acronym / sponsor ID: PCS499-NL01
Conditions: Necrobiosis Lipoidica
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Processa PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 7 Nov 2018 (actual)
Primary completion: 25 Feb 2020 (actual)
Study completion: 25 Feb 2020 (actual)
First posted: 9 Oct 2018 (actual)
Results: Posted 3 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PCS499 900mg twice a day	Experimental	Drug: PCS499deuterated pentoxifylline analog dosed twice a day at 900 mg

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.
Reference NL lesion with a score of 2 or greater on the Investigator Global Assessment: Necrobiosis Lipoidica (IGA:NL) Activity scale AND surface area with minimum size of 10 cm2. If more than one lesion is present, the reference lesion area is the lesion with the highest disease severity.
Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Baseline before dosing.
Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study: oral contraceptive medication, intrauterine device (IUD), hormonal implants, injectable contraceptive medications, double-barrier methods, or tubal ligation.

Key exclusion criteria (37 listed)

Current or previous (within 4 weeks of Baseline) treatment with:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCS499Also: deuterated pentoxifylline analogPCS499 900mg twice a day with food	Drug	PCS499 900mg twice a day

Primary outcome

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

Results and safety

Results posted to the registry on 3 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCS499 900mg Twice a Day	12	10

Primary outcome: Number of Participants With Adverse Events

Time frame: 12 months. Count of participants. Unit: Participants

Measure	PCS499 900mg Twice a Day n = 12
Value	10

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCS499 900mg Twice a Day	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12

Limitations and caveats (from the sponsor): open label study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42054009Rubenstein 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maya Das, MD study director

Processa Pharmaceuticals

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCS499 in people with Necrobiosis Lipoidica, run by Processa Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.