Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma

October 29, 2026 updated by: Nour Kibbi, Stanford University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm Title: Left Hand Hyaluronidase, Right Hand Control

Participants assigned to this arm will receive intradermal hyaluronidase injections in the left hand, while the right hand serves as an untreated control. Up to four treatment sessions will be administered at approximately monthly intervals. Both hands will undergo standardized assessments throughout the study.
Drug: hyaluronidase

Hyaluronidase (Amphadase) will be administered by intradermal injection into the randomly selected treatment hand using the commercially available formulation. Participants may receive up to four treatment sessions, at baseline and approximately months 1, 2, and 3, with a maximum dose of 150 USP units (1.0 mL) per session. The contralateral hand will receive no injections and serve as an untreated control throughout the 6-month study period.

Other Names:
  • Amphadase
Experimental: Right Hand Hyaluronidase, Left Hand Control

Participants assigned to this arm will receive intradermal hyaluronidase injections in the right hand, while the left hand serves as an untreated control. Up to four treatment sessions will be administered at approximately monthly intervals. Both hands will undergo standardized assessments throughout the study.
Drug: hyaluronidase

Hyaluronidase (Amphadase) will be administered by intradermal injection into the randomly selected treatment hand using the commercially available formulation. Participants may receive up to four treatment sessions, at baseline and approximately months 1, 2, and 3, with a maximum dose of 150 USP units (1.0 mL) per session. The contralateral hand will receive no injections and serve as an untreated control throughout the 6-month study period.

Other Names:
  • Amphadase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Different Between Hands in Change From Baseline in Modified Hand Mobility in Scleroderma (mHAMIS) Score
Time Frame: Baseline and Months 1, 2, 3, and 6

Hand mobility will be assessed using the modified Hand Mobility in Scleroderma (mHAMIS) score for each hand. Measurements will be obtained at baseline and months 1, 2, 3, and 6. Changes from baseline will be calculated separately for the hyaluronidase-treated hand and the contralateral untreated control hand. The primary outcome will be the within-participant difference in change in mHAMIS score between the treated and control hands. Score ranges from 0 to 12 for each hand. A higher score means a greater degree of hand dysfunction.
Baseline and Months 1, 2, 3, and 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference Between Hands in Change From Baseline in Regional Modified Rodnan Skin Score (mRSS)
Time Frame: Baseline and Months 1, 2, 3, and 6

Skin thickening will be assessed using the regional modified Rodnan Skin Score (mRSS) for each hand. Changes from baseline will be calculated separately for the hyaluronidase-treated and untreated control hands. Within-participant differences will be compared to evaluate changes in skin thickening over time . Score ranges from 0-3 for each area, with higher score indicating more severe skin thickening.
Baseline and Months 1, 2, 3, and 6
Difference Between Hands in Change From Baseline in Finger-to-Palm Distance
Time Frame: Baseline and Months 1, 2, 3, and 6

Finger-to-palm distance will be measured separately for each hand to assess finger flexion. Changes from baseline will be calculated for the hyaluronidase-treated hand and the contralateral untreated control hand. Within-participant differences will be compared to evaluate changes in finger mobility following treatment. A higher score (distance greater than 0 cm) means the finger is further from the palm.
Baseline and Months 1, 2, 3, and 6
Patient-Reported Pain Score in the Hyaluronidase-Treated Hand
Time Frame: Baseline and Months 1, 2, 3, and 6

Participants will report pain associated with the hyaluronidase-treated hand using a numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores will be recorded during treatment visits to evaluate treatment-related discomfort.
Baseline and Months 1, 2, 3, and 6
Number of Participants With Treatment-Related Adverse Events
Time Frame: Baseline and Months 1, 2, 3, and 6

The number of participants experiencing treatment-related adverse events will be recorded throughout the study.
Baseline and Months 1, 2, 3, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Nour Kibbi, MD, Stanford University
  • Study Director: Winnie Fan, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

October 29, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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