The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy...
SclerodermaStudy about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce inflammation, immunological response and fibrosis: A Randomized Clinical Placebo ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to July 2017
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
MorpheaThis is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma...
Raynaud's PhenomenonDigital Ulcers1 moreRaynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.
A Study of the Safety and Tolerability of MEDI-551 in Scleroderma
SclerodermaThe primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-551 over escalating single doses in adult subjects with Scleroderma
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With...
SclerodermaTo evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
SclerodermaSystemic Sclerosis2 moreThe 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.
Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
SclerodermaRaynaud's SyndromeThis is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control. Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner. Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed. At the conclusion of the study, unblinding will occur.
Zibotentan Better Renal Scleroderma Outcome Study
SclerodermaScleroderma Renal Crisis1 moreMany 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
Riociguat in Scleroderma Associated Digital Ulcers
SclerodermaDigital UlcersThe primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers
Effect of Bosentan in Scleroderma Renal Crisis
Scleroderma Renal CrisisSystemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.