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NCT Number: NCT07697274

Hyaluronidase for Sclerodactyly in Systemic Sclerosis 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.

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Key information

Conditions

Systemic Sclerosis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Sclerodactyly Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location contact

Kimberly Hashemi, MD

CONTACT

[email protected]

843-792-9784

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronidase (Hylenex)

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Estimate preliminary efficacy in digital range of motion

    Time frame: 28 weeks

    Change from baseline in digital range of motion using goniometry

  2. Estimate preliminary efficacy based on patient reported outcomes

    Time frame: 28 weeks

    Change from baseline in Cochin Hand Function Scale-6

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Hashemi, MD

CONTACT

[email protected]

943-792-9784

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis

Acronym: HASSc

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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