Clinical Trials for Scleroderma Associated Digital Ulcers
There is currently 1 ongoing clinical trial investigating new treatments for digital ulcers in patients with systemic sclerosis. This trial is testing TOP-N53, a topical nitric oxide-releasing gel designed to improve healing of painful finger sores. The study is being conducted in France and focuses on evaluating the safety and tolerability of this investigational treatment. (Also known as: Digital ulcers in systemic sclerosis, SSc-related digital ulcers)
Clinical trial locations
Study on the Safety of TOP-N53 for Treating Digital Ulcers in Systemic Sclerosis Patients
This clinical trial is investigating TOP-N53, a nitric oxide-releasing gel applied directly to digital ulcers in patients with systemic sclerosis. Digital ulcers are painful open sores on the fingers caused by reduced blood flow, a common complication of this condition that affects the skin and connective tissues.
Who can participate:
- Adults aged 18 to 69 years with diagnosed systemic sclerosis
- At least one active digital ulcer measuring at least 3 mm in diameter
- Either taking stable sildenafil treatment (20 mg three times daily for at least 2 weeks) or not taking any similar medications for at least 4 weeks
- Women of childbearing potential must use highly effective birth control throughout the trial and for at least 7 weeks afterward
- If taking other medications for systemic sclerosis (such as endothelin receptor antagonists, calcium channel blockers, or antiplatelets), doses must have been stable for at least 2 weeks
Who cannot participate:
- Patients with active untreated infections
- Those allergic to any ingredients in the study medication
- People currently participating in another clinical trial
- Patients who had major surgery within the last 4 weeks
- Those with severe heart disease, uncontrolled diabetes, or severe kidney or liver disease
- Pregnant or breastfeeding women
- Patients who had a stroke in the past 6 months
- Those with cancer that is not in remission
What the trial involves:
The study examines the safety and tolerability of TOP-N53 when applied directly to digital ulcers. Participants will receive different doses of the treatment (0, 2, 4, and 8 micrograms) to determine how well patients tolerate the medication. The treatment is applied for either 3 hours or, at the highest dose, 24 hours. A placebo (inactive substance) will be used for comparison.
Participants will attend an initial visit for consent and physical examination, followed by baseline assessments including vital signs, laboratory tests, and an electrocardiogram to check heart function. During the treatment phase, participants will keep a diary to record symptoms such as pain and itching. Regular assessments will monitor any side effects and evaluate the condition of the ulcers. A follow-up visit approximately 7 to 9 days after the last treatment will include final examinations and tests to ensure participant safety.
Investigational treatment:
TOP-N53 is a hydrogel medication applied directly to the wound. It works by releasing nitric oxide, a substance that helps widen blood vessels and improve blood flow, potentially promoting healing. The medication is classified as a nitric oxide-releasing phosphodiesterase-5 (PDE5) inhibitor.
Summary
Currently, only one clinical trial is actively recruiting patients with scleroderma-associated digital ulcers, conducted in France. This trial focuses specifically on testing the safety and tolerability of TOP-N53, a topical treatment that releases nitric oxide to improve healing. The study uses a dose-escalation approach to carefully evaluate how well patients tolerate different concentrations of the medication. While treatment options for digital ulcers in systemic sclerosis patients remain limited, this research represents an important step in exploring new therapeutic approaches that could potentially help manage these painful and debilitating complications. Patients interested in participating should discuss eligibility with their healthcare provider.
