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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Winnie Fan, MD
- Número de teléfono: 650-725-5272
- Correo electrónico: wfan3@stanford.edu
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
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.
Otros nombres:
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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. |
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Different Between Hands in Change From Baseline in Modified Hand Mobility in Scleroderma (mHAMIS) Score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference Between Hands in Change From Baseline in Regional Modified Rodnan Skin Score (mRSS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nour Kibbi, MD, Stanford University
- Director de estudio: Winnie Fan, MD, Stanford University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del tejido conectivo
- Enfermedades de la piel
- Enfermedades de la piel y del tejido conectivo
- Esclerodermia Sistémica
- Esclerodermia Difusa
- Hidrolasas de glucósidos
- Hidrolasas
- Enzimas
- Enzimas y coenzimas
- Polisacárido-liasas
- Liasas de oxígeno de carbono
- Liasas
- Esterasas
- Sulfatasas
- Hialuronoglucosaminidasa
- Condroitinasas y Condroitin Liasas
Otros números de identificación del estudio
- 88118
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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