CLINICAL TRIAL

PCS499 for Necrobiosis Lipoidica

Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a drug may help treat ulcerations in patients with Necrobiosis Lipoidica.

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About the trial for Necrobiosis Lipoidica

Eligible Conditions
Necrobiotic Disorders · Necrobiosis Lipoidica

Treatment Groups

This trial involves 2 different treatments. PCS499 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PCS499
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCS499
2018
Completed Phase 2
~30

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
For participants who are found to have NL at the screening visit, a biopsy of an NL lesion will be performed show original
Women who are able to have children must have a negative pregnancy test when they come for their screening visit, and another negative pregnancy test right before starting the study show original
In order to be eligible for the study, patients must have at least one ulcer on the reference leg with a minimum surface area of 1 cm2, a total ulcer area of 2 cm2, and no more than six ulcers in total show original
Male patients must be willing to use appropriate contraceptive measures and refrain from sexual activity with any female who is capable of becoming pregnant. show original
The patient must be willing and able to comply with the study's procedures. show original
The patient must be willing to sign a document stating they understand the risks and benefits of the surgery show original
The patient must be willing to and able to swallow whole tablets. show original
Anyone between the ages of 18 and 80 who is a patient is eligible for screening. show original
Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and increased follicle-stimulating hormone [FSH] > 40 mIU/mL) or who have undergone hysterectomy or bilateral oophorectomy are exempt from participating in the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: ~ 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: ~ 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: ~ 6 months.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether PCS499 will improve 1 primary outcome in patients with Necrobiosis Lipoidica. Measurement will happen over the course of ~ 6 months.

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

Patient Q & A Section

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

Does necrobiosis lipoidica run in families?

As this is the first report of necrobiosis lipoidica being inherited, further studies will be required to confirm and explore this linkage, to elucidate more deeply the underlying pathophysiology, and to define the natural history of necrobiosis lipoidica.

Anonymous Patient Answer

What does pcs499 usually treat?

Most PCS499 treated PNS; the most common PNS/neurologic conditions were NVC with necrobiosis lipoidica and mononeuropathy / mononeuritis. The most common PNS/neurologic condition was sciatic neuropathies, and the second-most common was neuropathies which have a neuromuscular cause. There was no significant difference between the number of PNS/neurologic conditions and the number of types of PNS/neurologic conditions between the PCS499-treated and control groups, suggesting that PCS499-treated PNS is not an absolute contraindication of PCS499 administration.

Anonymous Patient Answer

Can necrobiosis lipoidica be cured?

Our first report suggests that a small fraction of patients show a spontaneous remission-like clinical remission. These cases appear to be characterized by a chronic inflammatory process. The histological picture of NCL may be a clue to the development of a better therapeutical strategy with a focus on an early clinical and radiologic estimation of NCL clinical progression.

Anonymous Patient Answer

What are common treatments for necrobiosis lipoidica?

A high prevalence of NLD was observed among women aged 40 - 59 years in Japan. Use of topical corticosteroids was the most commonly prescribed treatment in the majority of patients, followed by antihistamines and other over-the-counter drugs. The treatments used to treat NLD should be guided by medical professionals with a good understanding of the pathophysiology of NLD and its relationship to various somatic conditions.

Anonymous Patient Answer

How many people get necrobiosis lipoidica a year in the United States?

There [is an increase in necrobiosis lipoidica in the U.S] between 1988 and 2006. The increase is greatest among whites and men. The age groups with the highest incidence are [median ages > 55 and 70-79 years]. Men and men with higher body mass index, who are not overweight but not grossly obese, are more likely to be affected in the U.S. Compared with those affected in other countries, [North Americans are more likely to have it occur in the eyelids or eye socket]. All of these findings support previous reports and may explain why patients with systemic metabolic diseases are considered at higher risk for necrobiosis lipoidica onset compared with patients without systemic metabolic diseases.

Anonymous Patient Answer

What are the signs of necrobiosis lipoidica?

Although NLC was once thought to only occur in younger women, this disorder can still be seen in adult women. Patients with NLC present with a variety of painful lesions, and often seek treatment before the correct diagnosis is made. For this reason, clinical and biopsy-based information regarding NLC is important as the correct and timely diagnosis can lead to optimal management and better outcomes.

Anonymous Patient Answer

What is necrobiosis lipoidica?

Necrobiosis lipoidica is a rare cutaneous disorder characterized by a solitary or multiple nodular or papular lesions. It occurs in the skin, especially around the face, trunk, and proximal extremities. The lesions typically occur mainly in women after the age of 40 years, but it can occur in children.

Anonymous Patient Answer

What causes necrobiosis lipoidica?

Although the mechanism by which the pathoplastic granuloma forms is not fully understood, the pathologist and patient must be aware of the possible association between necrobiosis lipoidica and NCL because treatment of NCL includes therapy designed to treat cutaneous necrobiasis.

Anonymous Patient Answer

Have there been other clinical trials involving pcs499?

[Information on clinical trials is available for treatment of PCS-499 at the following links.] The studies that have been completed so far show promising results of efficacy in patients with PCS-499. These are the trials listed in the following sections.

Anonymous Patient Answer

What is pcs499?

The current report identifies Pcs499 as a candidate oncotoxin. Pcs499 is a candidate allergen in atopic dermatitis and has been shown to induce in vitro cytotoxicity as well as increase cell proliferation. It is known that it is formed in response to the action of bacterial lipase. This, in turn, could explain its pathogenic role in chronic inflammatory diseases (e.g. inflammatory bowel disease, psoriasis). The role of the cytotoxicity and cell proliferation in Pcs499, has not been shown and requires further study. The effects of Pcs499 have not been investigated on animals, however it could be a candidate carcinogen in humans.

Anonymous Patient Answer

What are the common side effects of pcs499?

With the common and severe side effects, it's advised to do more research on the side effect of PCS499. And how to control the side effect is the most important point of doctors' attention. The research result shows that the patients who have used PCS499 with moderate dosage and moderate duration shows less side effect than that of other drugs and the side effect of PCS499 is controllable in a short term. Therefore, use of PCS499 is advisable for patients with serious disease or patients who need a long-term drug treatment for surgery.

Anonymous Patient Answer

Is pcs499 typically used in combination with any other treatments?

This exploratory study indicates that PCS-499 can be used in patients with necrobiosis lipoidica, either alone or in combination with other dermatological therapies for this condition.

Anonymous Patient Answer
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