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Scleroderma, Localized clinical trials

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NCT ID: NCT04837131 Terminated - Systemic Sclerosis Clinical Trials

A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.

NCT ID: NCT04804930 Recruiting - Clinical trials for Scleroderma, Systemic

Trichoscopy and Systemic Scleroderma

TRICHLOSCLERO
Start date: November 8, 2021
Phase:
Study type: Observational

- Few data are available on scalp involvement in systemic scleroderma. - Few data are available on the association between scalp abnormalities and features of systemic scleroderma - Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice - There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma

NCT ID: NCT04797286 Recruiting - Scleroderma Clinical Trials

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

SEPVADIS
Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.

NCT ID: NCT04752397 Completed - Clinical trials for Graft Vs Host Disease

The Influence of Extracorporeal Photopheresis on Skin Sclerosis

Start date: February 12, 2021
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP), also known as extracorporeal photoimmunotherapy or photochemotherapy, is a leukapheresis-based therapy that has been in clinical use for over three decades after receiving FDA approval in 1988. Extracorporeal photopheresis was initially used for the treatment of T-cell lymphoma. Since its introduction, indications for initiating ECP were continuously extended to the treatment of Graft-versus-Host Disease (GvHD), systemic sclerosis, and in the field of solid organ transplantation. There is also evidence supporting the use of ECP in generalized morphea, a form of scleroderma limited to the skin, and in eosinophilic fasciitis, which is a rare, localized fibrosing disorder of the fascia. Concluding the results of the published studies, there is evidence that ECP has a positive effect on fibrosing disorders of the skin. Furthermore, in clinical practice, it has been observed that patients with systemic sclerosis, who undergo ECP treatment, show improvement of the skin lesions or a deceleration in the formation progress of such lesions during the therapy. Same findings can be observed in patients with sclerotic skin lesions of the skin, for example in the context of a GvHD. There are no clinical studies so far that describe these processes using objective measuring methods. Furthermore, the mechanism of action of ECP in systemic sclerosis and other fibrosing disorders with skin manifestations, has not yet been conclusively clarified. Serological markers for monitoring the progress of the therapy and determining the prognosis are also missing. Thus, a consensus regarding the frequency and duration of ECP for the therapy of systemic scleroderma or sclerotic diseases has not yet been reached. This study aims at evaluating the influence of Extracorporeal Photopheresis on the quality and functionality of sclerotic skin lesions assessed by several objective methods. Furthermore, potential biomarkers, which are being investigated in current studies, are to be determined in order to evaluate the influence of ECP on those biomarkers and better understand the mechanism of action of ECP on systemic sclerosis and fibrosing disorders involving the skin.

NCT ID: NCT04746313 Recruiting - Scleroderma Clinical Trials

Prevalence of Hyperprolactinemia in Systemic Scleroderma

SCLERO-PRL
Start date: March 1, 2021
Phase:
Study type: Observational

Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin

NCT ID: NCT04684225 Completed - Rehabilitation Clinical Trials

Telerehabilitation on Hand-Affected Scleroderma

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

NCT ID: NCT04647890 Completed - Clinical trials for Scleroderma, Systemic

Effects of FT011 in Systemic Sclerosis

Start date: July 19, 2021
Phase: Phase 2
Study type: Interventional

FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).

NCT ID: NCT04610788 Recruiting - Scleroderma Clinical Trials

Cardiac Assessment by PV Loop in IPAH and Scleroderma PAH

CALIPSO
Start date: April 15, 2019
Phase:
Study type: Observational

This observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated PAH) and a weak heart muscle (heart failure). The study will also help the investigators understand why people with PAH from an unknown cause (called idiopathic PAH, or IPAH) can also develop a weakened heart muscle. The response of the right side of the heart or right ventricle (RV) to standard PAH therapy in scleroderma-associated PAH and in IPAH will be assessed. Blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. People with scleroderma-associated PAH or idiopathic cause (IPAH) who need a right heart catheterization may join this study.

NCT ID: NCT04567537 Active, not recruiting - Scleroderma Clinical Trials

Laser Treatment for the Improvement of Scars and Scleroderma

Start date: June 2, 2021
Phase: N/A
Study type: Interventional

In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.

NCT ID: NCT04563481 Not yet recruiting - Rehabilitation Clinical Trials

Effectiveness of Telerehabilitation on Scleroderma

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of traditional physiotherapy practices.