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Scleroderma, Diffuse clinical trials

View clinical trials related to Scleroderma, Diffuse.

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NCT ID: NCT06256575 Not yet recruiting - Clinical trials for Scleroderma, Systemic

Study of Diosmin-Diosmetin for the Treatment of Digital Ulcers in Systemic Sclerosis

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

This study is performed to consider the safety and healing ability of diosmin-diosmetin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). . The study will include 21-45 patients who will randomly be given either active product or inactive product (placebo). Two (2) out of every three (3) patients enrolled will receive active product. The patients will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle. Diosmin-Diosmetin is a naturally occurring compound found in citrus fruits and vegetables known as flavonoids. This product has been used to treat poor blood circulation in a variety of countries.

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: NCT06195072 Not yet recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 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: NCT06189495 Not yet recruiting - Clinical trials for Systemic Sclerosis Associated Interstitial Lung Disease

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease

Start date: December 30, 2023
Phase: Phase 2
Study type: Interventional

This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)

NCT ID: NCT06182293 Not yet recruiting - Clinical trials for Scleroderma Systemic

Periodontal Microbiota in Systemic Sclerosis

Periomicross
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background. Patients show a wide spectrum of clinical features including periodontitis, which is an inflammatory disease of the tooth-supporting tissues resulting from dysbiosis of the periodontal microbiota guided by inflammophilic bacteria. The microbiota plays a fundamental role in the induction, training, and function of the host immune system. Numerous studies have highlighted the impact of an altered microbiota, i.e. dysbiosis, on the pathogenesis of immune-mediated diseases. Indeed, commensals are important to maintain immune homeostasis and changes in the microbial composition can be responsible for a loss of tolerance. SSc has been shown to be associated with gut dysbiosis and a depletion of commensals. However, although the oral cavity is one of the two largest microbial habitats, only one study (only focusing on Lactobacillus species) has investigated the oral microbiota in SSc. As periodontal dysbiosis is known to induce low-grade systemic inflammation and represents a risk factor for the development of various autoimmune diseases, the relationship between periodontal microbiota composition and SSc merits further exploration. The aim of this pilot study is to characterize the taxonomic composition and metabolic pathways of the periodontal microbiota in SSc patients and age and sex-matched controls.

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: NCT06152172 Not yet recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

CARTIMMUNE
Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

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: 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.