Condition: Digital Ulcers in Systemic Sclerosis · Sponsor: Topadur Pharma AG
The main goal of this clinical trial is to learn about how safe the new drug TOP-N53 solution is when it is applied to open wounds on the fingertip (digital ulcers) in people with an uncommon illness that results in hard, thickened areas of skin and additional problems with internal organs and blood vessels (systemic sclerosis). Another goal is to learn if different strengths of TOP-N53 can treat certain aspects of the illness. Men and women between 18 and 69 years of age with this illness may participate in the clinical trial. A parallel treatment with Sildenafil 20 mg is allowed for clinical trial participants. The main questions the clinical trial aims to answer are: * Does TOP-N53 cause medical problems at the fingertip wound after it is directly applied to the wound? * Does TOP-N53 affect certain aspects of the illness like blood flow in the fingertip wounds, itch, pain, redness, bruises and bleeding at or beyond the fingertip wounds? Researchers will compare TOP-N53 solution in different strengths to a placebo (a look-alike substance that contains no drug) to see if TOP-N53 works to affect the aspects of the illness listed above. Participants will receive one or two treatments with the placebo or different strengths of TOP-N53. The higher strength of the drug will only be given to participants after the lower strength was found to be safe. Participants will visit the clinic up to 8 times within a maximum of 31 days. 2 visits may be done by telephone. The doctors wi…
This description comes directly from the study's public registry record.
Claudia Berger, Ph.D. · +41792025755 · claudia.berger@Topadur.com
Always discuss trial participation with your own doctor first.
| Centre Hospitalier Universitaire de Bordeaux, Service de Rhumatologie | Bordeaux, France | Recruiting |
| CHU Grenoble Alpes | La Tronche, France | Recruiting |
| CHRU Lille, Hôpital Claude Huriez, Rue Michel Polonosvski | Lille, France | Recruiting |
| AP-HP Hôpital Cochin | Paris, France | Recruiting |
| Reha Rheinfelden, Salinenstrasse 98 | Rheinfelden, Canton of Aargau, Switzerland | Recruiting |
| Universitätsspital Zürich, Klinik für Rheumatologie, Rämistrasse 100 | Zurich, Canton of Zurich, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06954597