15
Participants
Start Date
February 4, 2025
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2026
TOP-N53
TOP-N53 solution (IMP) containing 80 µg/ml TOP-N53 is applied topically directly to the digital ulcer of patients with systemic sclerosis. The dose if defined by volume and exposure time of the IMP.
Sildenafil
Parallel treatment with Sildenafil 20 mg 3-times per day is permitted if patient has been on a stable dose for 2 weeks prior to screening.
TOP-N53 vehicle
TOP-N53 vehicle solution will be topically applied to digital ulcers of systemic sclerosis patients.
RECRUITING
AP-HP Hôpital Cochin, Paris
RECRUITING
CHU Grenoble Alpes, La Tronche
Collaborators (1)
Bioskin GmbH
INDUSTRY
Topadur Pharma AG
INDUSTRY