Actively Recruiting
Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis
Led by Topadur Pharma AG · Updated on 2026-01-09
15
Participants Needed
5
Research Sites
60 weeks
Total Duration
On this page
Sponsors
T
Topadur Pharma AG
Lead Sponsor
B
Bioskin GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 will ask questions to ensure that it is safe for the participants to be in the clinical trial, apply the drug and follow-up on any medical problem after the treatment. They will also test if the drug works to treat the illness by several test methods before and after the treatment. Participants will help to find out whether the drug works to treat the illness and is safe by answering questions in a diary at different timepoints before and after treatment.
CONDITIONS
Official Title
Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow instructions during the clinical trial
- Signed informed consent before joining the trial
- Male or female aged 18 to 69 years with systemic sclerosis diagnosed by 2013 ACR/EULAR criteria
- At least one active fingertip digital ulcer 3 mm or larger involving the dermis
- Either on stable oral Sildenafil 20 mg three times daily for at least 2 weeks before screening or not on any oral PDE5 or unselective PDE inhibitors for at least 4 weeks before screening
- Physical exam without disease findings except systemic sclerosis unless considered irrelevant by investigator
- Stable doses of endothelin receptor antagonists, calcium channel blockers, and antiplatelets for at least 2 weeks before screening if applicable
- Female volunteers of childbearing potential must be permanently sterile or use effective birth control during the trial and for 7 weeks after last dose
- Male participants with female partners of childbearing potential must use adequate contraception
- Covered by health insurance or compliant with national biomedical research laws
You will not qualify if you...
- Digital ulcers with infection, osteitis, or gangrene
- Modified Rodnan Skin Score over 35
- Severe pain from digital ulcers (NRS 6 or higher)
- Active or past calcinosis at the ulcer site
- Unstable or poorly controlled systemic sclerosis organ involvement requiring urgent treatment
- Active or recent malignancy within 5 years except certain treated skin or prostate cancers
- Chronic liver disease or significant other diseases impacting safety or participation
- Low blood pressure or pulse rate below specified limits at screening
- Abnormal ECG findings including prolonged QT interval or arrhythmias
- Major surgery within 8 weeks before screening
- Elevated liver enzymes or bilirubin above 1.5 times normal
- Reduced kidney function with estimated glomerular filtration rate below 60 ml/min/1.73 m2
- Clinically significant lab abnormalities needing further evaluation
- Positive HIV, hepatitis B, or hepatitis C tests unless known from history
- Recent or ongoing treatments with IV prostanoids or certain oral vasodilators
- Use of other PDE5 inhibitors except allowed Sildenafil or unselective PDE inhibitors within specified periods
- Use of systemic glucocorticoids or immunosuppressants unless stable for 4 weeks before screening
- Contraindications to Sildenafil including hypersensitivity, use of nitrates, or history of vision loss due to NAION
- Allergies to study drug components or local anesthetics
- Participation in another clinical trial within 30 days or 60 days for certain drugs
- Pregnant or breastfeeding women
- Expected non-compliance or inability to complete the study
- Close relation to investigators or employees at study sites
- Institutionalized or legally protected individuals
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centre Hospitalier Universitaire de Bordeaux, Service de Rhumatologie
Bordeaux, France, 33000
Actively Recruiting
2
CHU Grenoble Alpes
La Tronche, France, 38 700
Actively Recruiting
3
CHRU Lille, Hôpital Claude Huriez, Rue Michel Polonosvski
Lille, France, 59000
Actively Recruiting
4
AP-HP Hôpital Cochin
Paris, France, 75014
Actively Recruiting
5
Reha Rheinfelden, Salinenstrasse 98
Rheinfelden, Canton of Aargau, Switzerland, 4310
Actively Recruiting
Research Team
C
Claudia Berger, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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