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Systemic Sclerosis clinical trials

View clinical trials related to Systemic Sclerosis.

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NCT ID: NCT06291142 Enrolling by invitation - Systemic Sclerosis Clinical Trials

Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Start date: November 22, 2023
Phase:
Study type: Observational

The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are: - Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report? - Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report - Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content. Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system. Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.

NCT ID: NCT06231433 Completed - Systemic Sclerosis Clinical Trials

Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

SCLERDERMCO2
Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days. At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

NCT ID: NCT06210945 Suspended - Systemic Sclerosis Clinical Trials

Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

ABATE
Start date: September 2024
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.

NCT ID: NCT06155578 Not yet recruiting - Systemic Sclerosis Clinical Trials

Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis

Cal-23
Start date: January 2, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This prospective placebo-controlled trial will enroll 20 patients with SSc and at least one calcinotic lesion of the hands that is palpable on physical examination and measurable on hand radiographs. Each subject will undergo a screening evaluation 1 month before treatment with the study drug is initiated. Each subject will be instructed to blindly self-apply either topical 25% sodium metabisulfite or placebo cream twice daily. In-person follow-up evaluations will be performed after 4-months, with monthly telehealth follow-up visits to ensure adherence and arrange study drug refill deliveries.

NCT ID: NCT06133244 Not yet recruiting - Systemic Sclerosis Clinical Trials

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Start date: January 2024
Phase:
Study type: Observational

Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.

NCT ID: NCT06095921 Completed - Systemic Sclerosis Clinical Trials

The Effect of a Self-Management Program on Individuals With Scleroderma

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease. Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction. Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

NCT ID: NCT06058091 Recruiting - Systemic Sclerosis Clinical Trials

RY_SW01 Cell Injection Therapy in Systemic Sclerosis

Start date: September 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.

NCT ID: NCT06051773 Not yet recruiting - Systemic Sclerosis Clinical Trials

Evaluation of Muscle Involvement in Systemic Sclerosis

MUSSc
Start date: January 1, 2024
Phase:
Study type: Observational

Muscle involvement is poorly described in patients with systemic sclerosis (SSc) . The prevalence of muscle damage is evaluated at 5-95 % of SSc patients, particularly due to variable definitions depending on the series in the scientific litterature. Muscle clinicobiological and histological presentation an response to immunosuppressive treatments are highly variable. Muscle involvement defined by creatinine kinase (CK) elevation, the presence of electromyography (EMG) abnormalities and/or muscle magnetic resonance imaging (MRI) hyperintensities and/or muscle biopsy inflammation appears to be associated with diffuse SSc, the presence of cardiac damage, and anti-PM-Scl antibodies. The main objective is to describe muscular manifestations associated with SSc. Secondary objectives are: - to compare characteristics between SSc patients with and without muscle involvement - to determine homogeneous groups of SSc patients with muscle involvement

NCT ID: NCT06029335 Active, not recruiting - Healthy Clinical Trials

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Start date: September 1, 2020
Phase:
Study type: Observational

Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases. Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.

NCT ID: NCT05989763 Not yet recruiting - Constipation Clinical Trials

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

TEA in SSc
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.