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NCT07916324
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Conditions: Scleroderma, Sclerodactyly, Systemic Sclerosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Stanford University
Location: Stanford University Stanford California
Summary
Systemic sclerosis can cause the skin of the fingers to become thick and tight, a condition called sclerodactyly. This can make it difficult to bend, straighten, and use the fingers. This study will evaluate whether intradermal injections of hyaluronidase (Amphadase) can improve hand mobility and function and will assess treatment-related side effects.
Approximately 10 adults with systemic sclerosis and sclerodactyly affecting both hands will participate at Stanford University. For each participant, one hand will be randomly selected by coin flip to receive hyaluronidase injections, while the opposite hand will serve as an untreated control. Participants may receive up to four injection sessions at baseline and approximately months 1, 2, and 3. Both hands will receive the same home exercise guidance throughout the study.
Participants will undergo assessments at baseline and months 1, 2, 3, and 6, including hand mobility and skin examinations, hand function questionnaires, and assessment of symptoms and adverse events. Researchers will compare changes between the treated and untreated hands. The investigator performing hand outcome assessments will be blinded to treatment assignment.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Documented diagnosis of scleroderma
* Clinically evident bilateral sclerodactyly involving both hands,
* Able and willing to comply with study visits and assessments.
* Able to provide written informed consent.
Exclusion Criteria:
* Age younger than 18 years.
* Unable to provide informed consent.
* Absence of bilateral sclerodactyly sufficient to permit treatment and comparison.
* Known hypersensitivity to hyaluronidase or any component of the study drug.
* Active infection, acute inflammation, or another condition at a planned injection site that would make intradermal injection unsafe.
* Pregnancy or anticipated pregnancy.
* Declines participation.
Source: ClinicalTrials.gov (NCT07916324). StuddyBuddy aggregates publicly available trial information.