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Efficacy and safety of hyaluronidase injection in morphea disease

Efficacy and safety of hyaluronidase injection in sclerotic lesions of morphea patients: a pilot study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251003067487N2
Enrollment
10
Registered
2025-11-20
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morphea. Localized scleroderma [morphea]

Interventions

Intervention 1: Intervention group: Hyaluronidase is injected on one side at a rate of 30 units per square centimeter (0.2 cc per square centimeter). To prepare hyalase, first dilute the 1500 unit via

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Has two relatively symmetrical sclerotic conditions Not using topical medications Patients who have been receiving systemic treatment with methotrexate or tofacitinib or mycophenolate mofetil for at least three months

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study History of allergy to lidocaine, hyalase, or bee stings Showing any complications or sensitivity after the injection Absence of symmetrical sclerotic lesions Receive topical medications

Design outcomes

Primary

MeasureTime frame
Localized Scleroderma Cutaneous Assessment Tool(LoSCAT). Timepoint: Each patient is given three injections at one-month intervals and is followed up for six months during three sessions 0-3-6. During each visit, patients rate the improvement from the injections using a scoring system from zero to 10. Method of measurement: Two dermatologists with experience in morphea give patients a clinical score based on the severity and activity of morphea A during each visit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Ansari

Tehran University of Medical Sciences

Ansarim2200@gmail.com+98 21 5561 8989

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026