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Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial

ConditionsSystemic SclerosisSclerodactyly
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and <60 years

Diagnosis of systemic sclerosis

Presence of sclerodactyly

Ability to provide informed consent

Disqualifiers

Known hypersensitivity to hyaluronidase

Pregnancy or breastfeeding

Unstable systemic disease

Recent changes in systemic immunomodulatory therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyaluronidase (Hylenex)

    Drug

    Patients will receive monthly injections of hyaluronidase into 1 finger on each hand over a 28 week treatment period.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intradermal HyaluronidaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility Assessment

The primary measures of feasibility will be study refusal rate and visit adherence during the treatment period. If the study refusal rate is more than 70% the study will be deemed unfeasible

Time frame
28 weeks
2

Evaluate Safety

Will monitor for adverse events and serious adverse events at every 4 week visit. All will be graded using Common Terminology Criteria for Adverse Events

Time frame
32 weeks

Secondary outcomes

1

Estimate preliminary efficacy in digital range of motion

Change from baseline in digital range of motion using goniometry

Time frame
28 weeks
2

Estimate preliminary efficacy based on patient reported outcomes

Change from baseline in Cochin Hand Function Scale-6

Time frame
28 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: