NCT07697274

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
14mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 1, 2026

Last Update Submit

July 8, 2026

Conditions

Systemic SclerosisSclerodactyly

Keywords

HyaluronidaseDigital fibrosisHand functionAutoimmune disease

Outcome Measures

Primary Outcomes (2)

  • 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

    28 weeks

  • 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

    32 weeks

Secondary Outcomes (2)

  • Estimate preliminary efficacy in digital range of motion

    28 weeks

  • Estimate preliminary efficacy based on patient reported outcomes

    28 weeks

Study Arms (1)

Intradermal Hyaluronidase

EXPERIMENTAL
Drug: Hyaluronidase (Hylenex)

Interventions

Hyaluronidase (Hylenex)DRUG

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

Intradermal Hyaluronidase

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 39307355BACKGROUND

  • 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.

    PMID: 37851438BACKGROUND

  • 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.

    PMID: 31141116BACKGROUND

  • 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.

    PMID: 31182129BACKGROUND

MeSH Terms

Conditions

Scleroderma, SystemicAutoimmune Diseases

Interventions

Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Central Study Contacts

Kimberly Hashemi, MD

CONTACT

943-792-9784bowerman@musc.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)