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NCT07916324Not yet recruitingPhase 2

Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma

Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis: A Prospective Split-Hand Controlled Pilot Study

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
29 Oct 2026
Start date
1 Dec 2026
Primary completion date
Sept 2027
Lead sponsor
Stanford University
NCT number
NCT07916324

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 10
  • From 1 Dec 2026 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Age

  • Age younger than 18 years.

Other

  • Unable to provide informed consent.
  • Absence of bilateral sclerodactyly sufficient to permit treatment and comparison.
  • Pregnancy or anticipated pregnancy.
  • Declines participation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Stanford University
Coordinator of this site? Confirm its status
StanfordUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.