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Scleroderma, Localized clinical trials

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NCT ID: NCT06195072 Recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

NCT ID: NCT06149260 Recruiting - Fibrosis Clinical Trials

Subcutaneous Semaglutide in Systemic Scleroderma

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

NCT ID: NCT05995626 Recruiting - Scleroderma Clinical Trials

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.

NCT ID: NCT05726630 Recruiting - Clinical trials for Systemic Scleroderma

Clinical Study of Divozilimab in Patients With Systemic Scleroderma

LIBERIUS
Start date: December 26, 2022
Phase: Phase 3
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.

NCT ID: NCT05085444 Recruiting - Autoimmune Diseases Clinical Trials

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

Start date: October 8, 2021
Phase: Early Phase 1
Study type: Interventional

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

NCT ID: NCT05041868 Recruiting - Quality of Life Clinical Trials

Rehabilitation Program in Patients With Scleroderma

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

Scleroderma (or Systemic Sclerosis - SSc) is one of the most neglected diseases worldwide, according to the World Health Organization. In the adult population with SS, the systemic effects of the disease, such as respiratory and peripheral muscle dysfunction, cause a decrease in quality of life. As a consequence, there is a concern about functional rehabilitation, since the aging of this population is already a reality. Thus, the objective of this project is to evaluate the effects of functional rehabilitation on functional capacity and quality of life in women over 18 years of SS. In this longitudinal intervention study, patients will be submitted to a three-month rehabilitation program. Before and after the intervention, patients will be submitted to the following assessments: Cochin Hand Functional Scale (CHFS), Short-Form 36 Health Survey (SF-36); Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI); lung function; lung ultrasound; handgrip; Glittre Activities of Daily Living test. Thus, it is expected that patients with SS will benefit significantly, with a consequent improvement in musculoskeletal function and , functional capacity and health-related quality of life.

NCT ID: NCT04954573 Recruiting - Clinical trials for Sclerotic Graft-versus-host Disease (GVHD)

Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This is a prospective, intra-individual comparative study to evaluate the effectiveness of local-water filtered infrared-A (wIRA) irradiation (applied by Hydrosun® radiator 750 for radiation at the clinic, or Hydrosun® 575home for home treatment) in patients with morphea or sclerotic GVHD (Graft-versus-host Disease). The purpose of the study is to determine whether wIRA irradiation can reduce fibrotic skin alterations in circumscribed scleroderma (morphea) or chronic graft versus host disease. wIRA irradiation is applied for 30 minutes 3 times per week for 20 weeks to a diseased skin area and a lesional skin on contralateral body site remains untreated. A total of 22 patients (20 evaluable patients with an expected drop-out rate of 10%) are to be included in this study. Group A: 11 patients with plaque morphea Group B: 11 patients with sclerotic GVHD.

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: 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