drugset / Trial / NCT07697274
Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2027-09
- Completion
- 2027-11
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rHuPH20 | Protein / enzyme biologic | — | Other |