Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Winnie Fan, MD
- 電話番号：650-725-5272
- メール：wfan3@stanford.edu
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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.
他の名前：
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実験的：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. |
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Different Between Hands in Change From Baseline in Modified Hand Mobility in Scleroderma (mHAMIS) Score
時間枠：Baseline and Months 1, 2, 3, and 6
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference Between Hands in Change From Baseline in Regional Modified Rodnan Skin Score (mRSS)
時間枠：Baseline and Months 1, 2, 3, and 6
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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
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Difference Between Hands in Change From Baseline in Finger-to-Palm Distance
時間枠：Baseline and Months 1, 2, 3, and 6
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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
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Patient-Reported Pain Score in the Hyaluronidase-Treated Hand
時間枠：Baseline and Months 1, 2, 3, and 6
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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
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Number of Participants With Treatment-Related Adverse Events
時間枠：Baseline and Months 1, 2, 3, and 6
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The number of participants experiencing treatment-related adverse events will be recorded throughout the study. |
Baseline and Months 1, 2, 3, and 6
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Nour Kibbi, MD、Stanford University
- スタディディレクター：Winnie Fan, MD、Stanford University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 88118
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国で製造され、米国から輸出された製品。
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