What this study is
Translational studies have demonstrated reduced hyaluronidase activity in the skin of patients with systemic sclerosis. It is thought this may contribute to the progressive fibrosis seen in this disease. Several studies have demonstrated that exogenous hyaluronidase is very effective at improving systemic sclerosis associated microstomia. Therefore, this study aims to explore hyaluronidase for systemic sclerosis associated sclerodactyly.
What's being tested
- Hyaluronidase (Hylenex)
Intervention · DRUG
Patients will receive monthly injections of hyaluronidase into 1 finger on each hand over a 28 week treatment period.
Study details
- Official title
- Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis
- Sponsor
- Medical University of South Carolina
- Conditions
- Systemic Sclerosis · Sclerodactyly
- Enrolling
- 10 people
- Starts
- 2026-11-01
- Est. completion
- 2027-11
- Design
- Open-label, single group, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥18 and <60 years
- Diagnosis of systemic sclerosis
- Presence of sclerodactyly
- Ability to provide informed consent
You can't join if
- Known hypersensitivity to hyaluronidase
- Pregnancy or breastfeeding
- Unstable systemic disease
- Recent changes in systemic immunomodulatory therapy
- Conditions interfering with safe digital injections
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMedical University of South Carolina
Charleston, South Carolina, United States
- Kimberly Hashemi, MD · Contact843-792-9784bowerman@musc.edu
Study team
Sponsor
Medical University of South Carolina
Study ID Pro00151042
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.