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Extracorporeal Photopheresis for Systemic Sclerosis
Study Summary
This trial will help researchers learn if a treatment called extracorporeal photopheresis is effective and safe for people with a disease called diffuse cutaneous systemic sclerosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 2 trial • 17 Patients • NCT00045305Trial Design
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Who is running the clinical trial?
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- I have early or active diffuse cutaneous systemic sclerosis.I do not have an ongoing infection needing treatment.I have a blood clotting disorder.I have a serious heart condition.I have undergone extracorporeal photopheresis before.I do not have any major health issues besides my current condition.I am 18 or older with systemic sclerosis.You must meet the specific classification criteria for systemic sclerosis set by ACR/EULAR in 2013.You have very low levels of hemoglobin in your blood.You have a low number of platelets in your blood.I have had my spleen removed surgically.You have tested positive for HIV.I am allergic to heparin or pork, or have had bad reactions to certain blood thinners.My lung function is significantly impaired.My condition is classified as severe pulmonary hypertension.You have a current, active infection of hepatitis B or C.I am not pregnant, breastfeeding, and if capable of childbearing, I use effective contraception.I have a condition that makes my skin extremely sensitive to light.I am taking more than 2 immunosuppressants.I do not have the natural lens in my eye, and it hasn't been replaced with an artificial one.I am not using any drugs that increase sensitivity to light.You had unusual reactions to psoralen compounds before.You have a very high number of white blood cells in your blood.
- Group 1: Administration of Extracorporeal Photopheresis Treatment
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies available in this research project?
"The clinicaltrials.gov database reveals that this trial, first published on September 1st 2022 and last revised April 11th 2022, is not currently accepting participants. Despite its inactivity, there are 521 other medical trials actively enrolling patients."
Are there any official certifications for the medicinal application of Extracorporeal Photopheresis (ECP) with Methoxsalen?
"Our team at Power has assessed the safety of Extracorporeal Photopheresis (ECP) with Methoxsalen to be a 2 as this is currently in Phase 2, indicating there is pre-existing data backing its security but none that validates efficacy."
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