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Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis

Research Study of an Investigational Treatment for Systemic Sclerosis (SSc) with Digital Ulcers

Recruiting
18-69 years
All
Phase 2

This study investigates the effects of an investigational treatment for individuals with Systemic Sclerosis (SSc) who have digital ulcers. Systemic Sclerosis, also known as scleroderma, is a chronic autoimmune disease characterized by hardening and tightening of the skin and connective tissues. Digital ulcers are painful sores that develop on the fingers or toes, often as a complication of SSc. The purpose of this study is to explore how the investigational treatment can impact the healing of these ulcers.

Participants in the study will undergo a series of procedures, including physical examinations and assessments of their ulcers. The study will involve taking either the investigational treatment or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Participants' health will be monitored closely throughout the study to evaluate the treatment's effects on ulcer healing and overall health outcomes.

  • Who can participate: Participants must be between 18 and 69 years old with a diagnosis of Systemic Sclerosis and at least one active digital ulcer. They should not have any severe complications or other significant health issues that could interfere with the study.
  • Study details: Participants will be required to take either the investigational treatment or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. They must continue any stable background treatments for SSc and adhere to the study's procedures and assessments.
Study details
    Digital Ulcers in Systemic Sclerosis

NCT06954597

Topadur Pharma AG

2 May 2025

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