Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial (HASSc)

July 8, 2026 updated by: Kimberly Hashemi, Medical University of South Carolina

Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic sclerosis (SSc) is a chronic autoimmune disease characterized by progressive fibrosis of the skin and internal organs. Sclerodactyly, a key manifestation, results in skin thickening, joint contractures, reduced digital range of motion, and significant functional impairment. There are currently no effective localized therapies to improve hand mobility in affected patients.

Hyaluronidase is an enzyme that degrades hyaluronic acid within the extracellular matrix and is widely used in dermatology with a well-established safety profile. Emerging evidence suggests that reduced endogenous hyaluronidase activity in SSc may contribute to impaired matrix turnover and persistent fibrosis. Intradermal hyaluronidase has demonstrated preliminary efficacy in improving tissue flexibility in SSc-associated microstomia, supporting its potential as a localized antifibrotic therapy.

This pilot study will evaluate the feasibility, safety, and preliminary efficacy of serial intradermal hyaluronidase injections for SSc-associated sclerodactyly. In an open-label, prospective design, 10 participants will undergo monthly treatment of two affected digits over 28 weeks. Outcomes will include change in digital range of motion measured by standardized goniometry and patient-reported hand function using the Cochin Hand Function Scale-6 (CHFS-6). Feasibility and safety will be assessed through recruitment, adherence, and systematic adverse event monitoring with predefined stopping criteria.

As an early-phase pilot, this study is not powered for hypothesis testing but is designed to generate the data necessary to inform a "go/no-go" decision for future trials. Results will provide critical estimates of feasibility, safety, and clinical signal to support the design of a subsequent randomized controlled trial and may establish a novel, localized therapeutic strategy for improving hand function in patients with systemic sclerosis.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 and <60 years
  • Diagnosis of systemic sclerosis
  • Presence of sclerodactyly
  • Ability to provide informed consent

Exclusion Criteria:

  • Known hypersensitivity to hyaluronidase
  • Pregnancy or breastfeeding
  • Unstable systemic disease
  • Recent changes in systemic immunomodulatory therapy
  • Conditions interfering with safe digital injections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intradermal Hyaluronidase
Drug: Hyaluronidase (Hylenex)
Patients will receive monthly injections of hyaluronidase into 1 finger on each hand over a 28 week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Assessment
Time Frame: 28 weeks
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
28 weeks
Evaluate Safety
Time Frame: 32 weeks
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
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate preliminary efficacy in digital range of motion
Time Frame: 28 weeks
Change from baseline in digital range of motion using goniometry
28 weeks
Estimate preliminary efficacy based on patient reported outcomes
Time Frame: 28 weeks
Change from baseline in Cochin Hand Function Scale-6
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00151042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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