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Systemic SclerosisEarly Phase 1HASScNCT07697274

Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial

A Early Phase 1 study testing Hyaluronidase (Hylenex) in people with Systemic Sclerosis and Sclerodactyly, run by Medical University of South Carolina at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Systemic Sclerosis, Sclerodactyly
What is being tested?
Hyaluronidase (Hylenex)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to Nov 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kimberly Hashemi, MD contact

943-792-9784

bowerman@musc.edu

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Kimberly Hashemi, MD, 843-792-9784, bowerman@musc.edu

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Hyaluronidase (Hylenex)
Keywords
Hyaluronidase, Digital fibrosis, Hand function, Autoimmune disease
Medical subject headings
Scleroderma, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronidase (Hylenex)Drug

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

Study groups in NCT07697274
Study groupRoleWhat they receive
Intradermal HyaluronidaseExperimentalNot described
Receives: Drug: Hyaluronidase (Hylenex)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 32 weeks

Secondary outcomes (2)

  1. Estimate preliminary efficacy in digital range of motion

    Change from baseline in digital range of motion using goniometry

    Measured: 28 weeks

  2. Estimate preliminary efficacy based on patient reported outcomes

    Change from baseline in Cochin Hand Function Scale-6

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697274
Sponsor's protocol ID
Pro00151042
Acronym
HASSc
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • E. Kilic, G. Kilic, G. Karadas, O. Akgul, M. Aytekin, M.F. Sonmez, S. Ozgocmen, AB0210 Serum and Tissue Levels of Hyaluronan in Patients with Systemic Sclerosis, Annals of the Rheumatic Diseases, Volume 74, Supplement 2, 2015, Page 961, ISSN 0003-4967, https://doi.org/10.1136/annrheumdis-2015-eular.5078.

  • Elgash M, Kim SR, Swallow M, Hinchcliff M, Suozzi K. Perioral hyaluronidase injection for the treatment of microstomia in systemic sclerosis patients: A retrospective cohort study. J Am Acad Dermatol. 2025 Jan;92(1):148-150. doi: 10.1016/j.jaad.2024.09.019. Epub 2024 Sep 21. No abstract available.

    PubMed 39307355

  • Min MS, Goldman N, Mazori DR, Guo LN, Vleugels RA, LaChance AH. Hyaluronidase Injections for Oral Microstomia in Systemic Sclerosis and Mixed Connective Tissue Disease. JAMA Dermatol. 2023 Dec 1;159(12):1393-1395. doi: 10.1001/jamadermatol.2023.3893.

    PubMed 37851438

  • Melvin OG, Hunt KM, Jacobson ES. Hyaluronidase Treatment of Scleroderma-Induced Microstomia. JAMA Dermatol. 2019 Jul 1;155(7):857-859. doi: 10.1001/jamadermatol.2019.0585. No abstract available.

    PubMed 31141116

  • Reissner L, Fischer G, List R, Taylor WR, Giovanoli P, Calcagni M. Minimal detectable difference of the finger and wrist range of motion: comparison of goniometry and 3D motion analysis. J Orthop Surg Res. 2019 Jun 10;14(1):173. doi: 10.1186/s13018-019-1177-y.

    PubMed 31182129

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hyaluronidase (Hylenex) in people with Systemic Sclerosis and Sclerodactyly, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kimberly Hashemi, MD (943-792-9784, bowerman@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Assessment (time frame: 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07697274, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.

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