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Research summary · AI summary · not yet reviewedHuman studyPhase 2Trial registry
Human Safety Study of TOP-N53 Solution for Digital Ulcers in Systemic Sclerosis
A Phase 2 clinical trial is underway to evaluate the safety and tolerability of the TOP-N53 solution applied topically to digital ulcers in patients with systemic sclerosis. The study compares the solution to a placebo, focusing on local treatment emergent adverse events (TEAEs).
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the safety profile of TOP-N53 could inform future treatment options for systemic sclerosis patients, who suffer from digital ulcers due to their condition.
What this does not prove
No results have been posted yet; the current information reflects planned enrollment and endpoints rather than actual findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (7)
study phasePHASE2
subjectsParticipants who are able to understand and follow instructions during the clinical trial.\n2.
intervention"description": "TOP-N53 solution (IMP) containing 80 µg/ml TOP-N53 is applied topically directly to the digital ulcer of patients with systemic sclerosis.
comparatorCurrently enrolled in another clinical investigation or clinical trial, or less than 30 days prior to screening visit (V0) (less than 2 months for any investigative clinical trials with PDE5 inhibitors, guanylate cyclase activators or stimulators, or any other intervention interfering with the broader cGMP pathway) since ending another clinical investigation or clinical trial(s), or receiving other investigational treatment(s).\n26.
primary endpoint"measure": "Local treatment emergent adverse events (TEAEs)",
findings"briefSummary": "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).
limitationsPlanned enrolment and endpoints are not findings.
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