RecruitingPHASE2INTERVENTIONAL

A Randomized Multicenter Study for Isolated Skin Vasculitis

This research study is for people with a skin condition called vasculitis, where the small blood vessels in the skin become inflamed. It's specifically for those whose vasculitis only affects their skin and isn't linked to other serious body problems. We are comparing three standard medications – colchicine, dapsone, and azathioprine – to find out which is most effective. Participants will take one medicine for six months. If it doesn't work well or causes problems, they'll be switched to another medicine for another six months. The study aims to improve treatments for primary cutaneous vasculitis, cutaneous polyarteritis nodosa, and IgA vasculitis (Henoch-Schönlein purpura).

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Pennsylvania

Enrolment target

Start

01 Jan 2017

Estimated completion

31 Dec 2028

Primary Cutaneous Vasculitis Cutaneous Polyarteritis Nodosa IgA Vasculitis Henoch-Schönlein Purpura

What is this study about?

Imagine your skin's tiny blood vessels becoming inflamed – that's vasculitis. This study focuses on a type called 'isolated skin vasculitis,' meaning the problem only affects your skin and isn't causing serious issues elsewhere in your body. Conditions like primary cutaneous vasculitis, cutaneous polyarteritis nodosa, and IgA vasculitis (also known as Henoch-Schönlein purpura) are all types of skin vasculitis being looked at.

The main goal of this study is to compare three commonly used medications: colchicine, dapsone, and azathioprine. Doctors already use these treatments for skin vasculitis, but we want to understand which one works best, how well they control the condition, and if some have fewer side effects than others. By doing this research, we hope to help doctors make better choices about which treatment to start with for future patients.

This study is important because finding the most effective treatment early can significantly improve a patient's quality of life, reduce flares, and might help prevent the condition from getting worse or spreading. It's about figuring out the best way to help people manage their skin vasculitis.

Key takeaways

The study is about finding the best common treatment for skin-only vasculitis.
It compares three existing medicines: colchicine, dapsone, and azathioprine.
You'll take one medicine for 6 months, and might switch if it's not working well.
Regular health checks and follow-up will be part of your participation.
The study may last up to 12 months in total.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is looking for adults aged 18 and over who have a type of vasculitis that only affects their skin. This means the blood vessel inflammation is showing up mainly in your skin, and you don’t have other serious related problems in your organs that need different strong treatments.

Specifically, you might be eligible if you have a diagnosis of isolated cutaneous small vessel vasculitis, medium-sized vessel vasculitis, cutaneous polyarteritis nodosa, or IgA vasculitis (Henoch-Schönlein purpura). For IgA vasculitis, it's important that your kidneys are working well and are not getting worse.

To be included, your vasculitis must have been confirmed by a skin biopsy, and you need to have active skin lesions (patches or spots) from the vasculitis at the time you join, or have had at least two flare-ups in the last six months. Don't worry if you've already tried one of the study drugs and it didn't work, you might still be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has a doctor told you that you have primary cutaneous vasculitis, cutaneous polyarteritis nodosa, or IgA vasculitis (Henoch-Schönlein purpura)?
Does your vasculitis mainly affect your skin, without causing serious problems in other body organs that need strong treatment?
Do you have active skin patches or spots from vasculitis now, or have you had at least two flare-ups in the last six months?
Has your vasculitis diagnosis been confirmed by a skin biopsy?
If you have IgA vasculitis, are your kidneys stable and working well?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to take one of three medications (colchicine, dapsone, or azathioprine) for six months. You'll take these medicines as tablets, usually twice a day for colchicine, once a day for dapsone, or adjusted for azathioprine, as directed by the study team.

You will have regular check-ups with the study team during this time to monitor how you're responding to the treatment and to check for any side effects. If, during these six months or in the following six months, your first medicine isn't working well, causes new problems, or your vasculitis flares up, you'll have the chance to be randomly assigned to one of the other two medications for another six months.

The study involves regular visits to the hospital or clinic for assessments, which will include physical examinations and possibly blood tests, to track your condition. The total duration for your involvement in the study could be up to 12 months, depending on how your treatment progresses.

Potential risks and benefits

Taking part in this study could potentially offer you a closer look at your condition and access to standard treatments under careful medical supervision. While there's no guarantee that any of the treatments will work for you, finding a medication that helps your skin vasculitis could improve your symptoms and quality of life. As with all medications, there's a risk of side effects, which will be carefully monitored by the study team. You'll be given detailed information about the possible side effects of each drug. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (16)

University of Kansas Medical Center
Verified postcode
Kansas City, United States· Recruiting
Boston University School of Medicine
Verified postcode
Boston, United States· Completed
Mayo Clinic
Verified postcode
Rochester, United States· Completed
Northwell Health
Verified postcode
Lake Success, United States· Completed
Hospital for Special Surgery
Verified postcode
New York, United States· Completed
Cleveland Clinic
Verified postcode
Cleveland, United States· Completed
Penn State Hershey Medical Center
Verified postcode
Hershey, United States· Completed
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Vanderbilt University
Verified postcode
Nashville, United States· Recruiting
UT Southwestern Medical Center
Verified postcode
Dallas, United States· Recruiting
University of Utah
Verified postcode
Salt Lake City, United States· Completed
University of Virginia
Verified postcode
Charlottesville, United States· Recruiting

Common questions

What is vasculitis?

Vasculitis is a condition where your body's small blood vessels become inflamed. In this study, we're focusing on cases where it mainly affects the skin.

What happens if the first medicine doesn't work for me?

If your first medicine isn't working well or causes problems, you could be randomly switched to one of the other two medicines in the study for another six months.

Will I have to pay for the study medications?

No, all study-related medications and assessments will be provided at no cost to you.

How long will I be in the study?

You could be in the study for up to 12 months, depending on how your treatment goes and if you switch medications.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.

How to find out more

Carol McAlear, MA

cmcalear@upenn.edu Official trial record

Always speak to your GP or specialist before deciding to take part in a study.