Safety and Effects of TOP-N53 Applied to Fingertip Wounds in Adults With Systemic Sclerosis

What this Trial Is About

Researchers are studying the safety and effects of a new drug called TOP-N53 solution when applied directly to open fingertip wounds digital ulcers in people with systemic sclerosis, a rare disease causing thickened skin and blood vessel problems. This Phase 2a trial also examines whether different doses of TOP-N53 can improve symptoms like blood flow, itch, pain, redness, bruising, and bleeding at or near the wounds. Participants aged 18 to 69 with systemic sclerosis and digital ulcers may take part, and the study allows concurrent use of Sildenafil 20 mg if stable. Participants will receive one or two treatments of either placebo or varying strengths of TOP-N53 applied topically to the fingertip ulcer. The study uses a sequential design where higher doses are given only after confirming safety at lower doses. Treatments include 3-hour and 24-hour exposures to different TOP-N53 concentrations or placebo. The trial involves up to five treatment steps with specific dosing regimens, including a placebo control. During up to 8 visits over a maximum of 31 days, including 2 possible telephone visits, participants will be monitored for safety and treatment effects. Assessments include physical exams, questionnaires about symptoms such as pain and itching recorded in diaries, and clinical evaluations of the ulcers redness, bruising, hemorrhage, edema, and infection. Researchers will track adverse events and other outcomes for up to 37 days following the first treatment to understand the drugs impact and tolerability.

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