Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis (TOP-N53-02)

Study of a topical study medicine for fingertip ulcers in systemic sclerosis

Age
18 years or above
Gender
All
participants needed
15
Locations
5
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Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Digital Ulcers in Systemic Sclerosis
  • Age: 18 years or above
  • Gender: All

The purpose of this research study is to learn about the safety and tolerability of a study medicine when it is put directly on open fingertip wounds (digital ulcers) in adults with systemic sclerosis. Systemic sclerosis is an uncommon illness that can cause hard, thickened skin and can also affect internal organs and blood vessels. The study will also look at whether different strengths of the study medicine affect things like blood flow at the wound, itch, pain, redness, bruising, and bleeding.

Participants will receive 1 or 2 treatments of either the study medicine (in different strengths) or a placebo. A placebo looks like the study medicine but does not contain any medicine. The higher strength will only be given after the lower strength is found to be safe. Some participants may also take sildenafil during the study.

Participants will visit the clinic up to 8 times over a maximum of 31 days, and up to 2 visits may be done by telephone. The study team will check whether it is safe for participants to be in the study, put the study medicine on the fingertip wound, and follow up on any medical problems after treatment. Participants will also complete a diary with questions at different times before and after treatment.

Who can participate:
Adults with systemic sclerosis and fingertip digital ulcers may be able to participate if they:

  • Are 18 to 69 years old
  • Have systemic sclerosis
  • Have an open fingertip wound (digital ulcer)

Study timeline and visits:
Participation lasts up to 31 days. There will be up to 8 clinic visits, and up to 2 of these visits may be done by telephone.

Updated on 06 Aug 2026. Study ID: TOP-N53-02

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