Hyaluronidase for Systemic Sclerosis

(HASSc Trial)

This trial tests whether hyaluronidase, an enzyme, can treat sclerodactyly, a condition where fingers and toes become stiff and tight due to systemic sclerosis, which causes skin hardening. The goal is to determine if injecting hyaluronidase directly into the skin can improve symptoms. Individuals diagnosed with systemic sclerosis and sclerodactyly might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

A previous study found hyaluronidase to be safe and effective. Tested at a dose of 25 micrograms per kilogram per day, it improved skin disease in people with scleroderma, a condition similar to systemic sclerosis. Participants tolerated the treatment well, with no major side effects reported. Another source noted that hyaluronidase is generally safe, with few adverse effects. This information should reassure those considering clinical trials that the treatment has been safely used in similar conditions.¹²³⁴⁵

Unlike the standard care for systemic sclerosis, which often involves immunosuppressive drugs and therapies that target inflammation, Hyaluronidase (Hylenex) offers a unique approach by breaking down hyaluronic acid in the skin. This enzymatic action helps to reduce the excessive skin thickening and stiffness that characterize the condition. Researchers are excited about Hylenex because it could potentially provide a more direct way to improve skin flexibility and function, with fewer systemic side effects compared to traditional treatments.

Research has shown that hyaluronidase, administered as an intradermal injection in this trial, can address issues related to systemic sclerosis. For instance, studies have found it effective in treating microstomia, a condition that restricts mouth opening in people with systemic sclerosis. In one study, 80% of participants experienced thicker upper lips and could open their mouths wider within a month. Evidence also indicates that hyaluronidase can reduce chronic muscle stiffness in other conditions, suggesting it might alleviate stiffness caused by systemic sclerosis as well. Overall, early results are promising for using hyaluronidase to manage symptoms of systemic sclerosis.⁶⁷⁸⁹¹⁰