Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronidase (Hylenex).
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis, Sclerodactyly. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis
Overview
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.
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.
Interventions
- Drug Hyaluronidase (Hylenex)
Patients will receive monthly injections of hyaluronidase into 1 finger on each hand over a 28 week treatment period.
Primary outcome measures
- Feasibility Assessment [Time frame: 28 weeks]
- Evaluate Safety [Time frame: 32 weeks]
Secondary outcome measures (2)
- Estimate preliminary efficacy in digital range of motion [Time frame: 28 weeks]
- Estimate preliminary efficacy based on patient reported outcomes [Time frame: 28 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
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. PMID 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. PMID 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. PMID 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. PMID 31182129
Identifiers
NCT: NCT07697274 · Pro00151042