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Scleroderma, Localized clinical trials

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NCT ID: NCT02396238 Completed - Systemic Sclerosis Clinical Trials

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)

STAR
Start date: May 15, 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

NCT ID: NCT02222038 Completed - Morphea Clinical Trials

Genetic Variants in Linear Localized Scleroderma

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the genetic architecture of Linear Localized Scleroderma (LLS) (linear morphea) by whole exome sequencing.

NCT ID: NCT02213705 Completed - ADULT Clinical Trials

Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells

MSC
Start date: May 6, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.

NCT ID: NCT02062125 Completed - Scleroderma Clinical Trials

Calcinosis in a Single-Center Scleroderma Population

SSc-calcinosis
Start date: October 31, 2012
Phase:
Study type: Observational [Patient Registry]

This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis 2) to identify common complications associated with scleroderma-related calcinosis. .

NCT ID: NCT02047708 Completed - Clinical trials for Chronic Kidney Disease

Zibotentan Better Renal Scleroderma Outcome Study

ZEBRA
Start date: October 2014
Phase: Phase 2
Study type: Interventional

Many patients with scleroderma have damage to their kidneys caused by the disease. There is limited evidence for treatments to prevent this damage or stop it progressing. Blocking a substance in the blood called endothelin has helped treat some aspects of scleroderma. The purpose of this study is to see how effective a new endothelin blocker called Zibotentan is in treating patients who have scleroderma and have gone on to develop reduced kidney function as a complication. It will be given in addition to the accepted treatments used for scleroderma. There will be three parts to this study each for a different group of patients: - ZEBRA 1 for patients with mild or moderate kidney disease caused by scleroderma - ZEBRA 2A for patients with a more severe, acute form of kidney disease caused by scleroderma (scleroderma renal crisis) who do not require dialysis - ZEBRA 2B for patients who have had scleroderma renal crisis and are on dialysis

NCT ID: NCT02006420 Completed - Scleroderma Clinical Trials

Scleroderma ARFI Imaging of the Skin

ARFI
Start date: December 2013
Phase:
Study type: Observational

Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening. Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy. The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI). The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin. This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.

NCT ID: NCT01959815 Completed - Clinical trials for Pulmonary Arterial Hypertension

Novel Screening Strategies for Scleroderma PAH

Start date: September 26, 2013
Phase:
Study type: Observational

Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.

NCT ID: NCT01881529 Completed - Diffuse Scleroderma Clinical Trials

A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

Start date: April 2013
Phase: N/A
Study type: Observational

To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.

NCT ID: NCT01799174 Completed - Morphea Clinical Trials

Treatment Study Comparing UVA-1 Phototherapy Versus Placebo Treatment for Morphea

Start date: May 2012
Phase: N/A
Study type: Interventional

This is a randomized, blinded, and controlled trial to assess the efficacy and safety of UVA1 phototherapy in the treatment of active morphea in adults and children. Forty patients will be randomized to receive either medium dose (70 J/cm2) phototherapy (active UVA1 phototherapy) with an ultraviolet translucent acrylic screen or "sham" UVA1 (0 J/cm2) phototherapy with an ultraviolet opaque acrylic screen 3 times per week for 10 weeks. The phototherapists, patients, and principal investigator will be blinded to whether the patients receive active or sham UVA1 phototherapy. Patients will only be allowed to apply emollients during the study. Patients completing the randomized placebo controlled trial (RPCT) will be followed during an open observation period for 3 months. During the open phase, all outcome measures from the RPCT (LoSSI, PGA-A) will be assessed every 5 weeks as well as adverse events. Patients who received sham UVA1 phototherapy will be invited to receive active UVA1 phototherapy using the same protocol as in the RPCT during the open observation. Adult patients enrolled in the RPCT will also be part of a nested translational study investigating the effect of UVA1 phototherapy on gene expression from whole skin biopsies taken before (Study Visit 1) and after UVA1 phototherapy (Study Visit 3). Gene expression profiles will be compared in lesional skin before and after treatment as well as nonlesional skin.

NCT ID: NCT01762449 Completed - Scleroderma Clinical Trials

Morbidity and Mortality Follow Up for the Scleroderma Lung Study

Start date: July 2012
Phase: N/A
Study type: Observational

The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.