SclerodermaPhase 2NCT07916324
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
A Phase 2 study testing hyaluronidase in people with Scleroderma and Sclerodactyly, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Sclerodactyly, Systemic Sclerosis
- What is being tested?
- hyaluronidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Scleroderma, Sclerodactyly, Systemic Sclerosis
- Being tested
- hyaluronidase
- Keywords
- Hyaluronidase, Amphadase, Scleroderma, Hand function, Finger mobility, Skin fibrosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronidaseDrug
Also called Amphadase
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 United States Pharmacopeia (USP) units, 1.0 milliliter (mL) per session. The contralateral hand will receive no injections and serve as an untreated control throughout the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Arm Title: Left Hand Hyaluronidase, Right Hand Control | Experimental | 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. Receives: Drug: hyaluronidase |
| Right Hand Hyaluronidase, Left Hand Control | Experimental | 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. Receives: Drug: hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Hands in Change From Baseline in Modified Hand Mobility in Scleroderma (mHAMIS) Score
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.
Measured: Baseline and Months 1, 2, 3, and 6
Secondary outcomes (4)
Difference Between Hands in Change From Baseline in Regional Modified Rodnan Skin Score (mRSS)
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.
Measured: Baseline and Months 1, 2, 3, and 6
Difference Between Hands in Change From Baseline in Finger-to-Palm Distance
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.
Measured: Baseline and Months 1, 2, 3, and 6
Patient-Reported Pain Score in the Hyaluronidase-Treated Hand
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.
Measured: Baseline and Months 1, 2, 3, and 6
Number of Participants With Treatment-Related Adverse Events
The number of participants experiencing treatment-related adverse events will be recorded throughout the study.
Measured: Baseline and Months 1, 2, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Kibbi, Stanford University
- Investigators
- Nour Kibbi, MD, Principal investigator, Stanford UniversityWinnie Fan, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916324
- Sponsor's protocol ID
- 88118
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whittelsey M, Mahajan A, Grullon K, LaChance A, Hashemi K. Digital Intradermal Hyaluronidase Injections for Sclerodactyly in Systemic Sclerosis. JAMA Dermatol. 2026 Jul 1;162(7):755-756. doi: 10.1001/jamadermatol.2026.0772.
PubMed 42126861
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis: A Prospective Split-Hand Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07916324
- Acronym / sponsor ID
- 88118
- Conditions
- Scleroderma, Sclerodactyly, Systemic Sclerosis
- Keywords
- Hyaluronidase, Amphadase, Scleroderma, Hand function, Finger mobility, Skin fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Title: Left Hand Hyaluronidase, Right Hand Control | Experimental | Drug: hyaluronidaseParticipants 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. |
| Right Hand Hyaluronidase, Left Hand Control | Experimental | Drug: hyaluronidaseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronidaseAlso: AmphadaseHyaluronidase (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 United States Pharmacopeia (USP) units, 1.0 milliliter (mL) per session. The contralateral hand will receive no injections and serve as an untreated control throughout the 6-month study period. | Drug | Arm Title: Left Hand Hyaluronidase, Right Hand Control, Right Hand Hyaluronidase, Left Hand Control |
Primary outcome
Difference 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.
4 secondary outcomes
Difference Between Hands in Change From Baseline in Regional Modified Rodnan Skin Score (mRSS)
Time frame: 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
Patient-Reported Pain Score in the Hyaluronidase-Treated Hand
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 42126861Whittelsey M, Mahajan A, Grullon K, LaChance A, Hashemi K. Digital Intradermal Hyaluronidase Injections for Sclerodactyly in Systemic Sclerosis. JAMA Dermatol. 2026 Jul 1;162(7):755-756. doi: 10.1001/jamadermatol.2026.0772.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nour Kibbi, MD principal investigator
Stanford University
Winnie Fan, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hyaluronidase in people with Scleroderma and Sclerodactyly, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winnie Fan, MD (650-725-5272, wfan3@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Hands in Change From Baseline in Modified Hand Mobility in Scleroderma (mHAMIS) Score (time frame: Baseline and Months 1, 2, 3, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.