A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Официальное название

A Prospective Cohort Study on the Efficacy and Safety Comparison of Tofacitinib Citrate Tablets Combined With Acitretin Capsules Versus Acitretin Capsules Alone in the Treatment of Primary Cutaneous Amyloidosis

Обзор

The aim of this clinical trial is to find out whether the combination of tocilizumab tablets and acitretin capsules is more effective than acitretin capsules alone in treating primary cutaneous amyloidosis. It will also investigate the safety of the combination of tocilizumab tablets and acitretin capsules. The main questions it aims to answer are: 1. Does the combination of tocilizumab tablets and acitretin capsules relieve the pruritus symptoms of the participants faster and reduce the pruritus score more than acitretin capsules alone? 2. What medical problems will the participants encounter when taking tocilizumab tablets combined with acitretin capsules? The researchers compared the combination of tocilizumab tablets and acitretin capsules with acitretin capsules alone to see if the combination could better treat primary cutaneous amyloidosis without causing serious adverse reactions. Participants will: 1. Take the combination of tocilizumab tablets and acitretin capsules or acitretin capsules alone every day for 16 weeks. 2. Visit the clinic once every 4 weeks for checkups and tests. 3. Observe participants at 4 weeks, 12 weeks and 24 weeks after discontinuation of medication to determine the recurrence status. 4. Collect the visual analogue scale (VAS) scores for pruritus, symptom severity (SCORAD) scores , rash area and severity, treatment response (EASI) scores, dermatological quality of life index (DLQI), and insomnia severity index (ISI) of participants before and after treatment.

Вмешательства

• Препарат Tofacitinib and Acitretin Capsules.
  The same with Arms.
• Препарат Acitretin Capsules.
  The same with Arms.

Первичные конечные точки

• Visual analogue scale (VAS) scores for pruritus. [Срок оценки: Week 0, Week 4, Week 8, Week 12 and Week 16.]

Вторичные конечные точки (7)

• SCORAD index. [Срок оценки: Week 0, Week 4, Week 8, Week 12 and Week 16.]
• EASI Index. [Срок оценки: Week 0, Week 4, Week 8, Week 12 and Week 16.]
• DLQI. [Срок оценки: Week 0, Week 4, Week 8, Week 12 and Week 16.]
• ISI. [Срок оценки: Week 0, Week 4, Week 8, Week 12 and Week 16.]
• The onset time of drug efficacy. [Срок оценки: Up to 8 weeks.]
• Recurrence rate. [Срок оценки: Within 24 weeks after the treatment concludes.]
• Incidence rate of adverse events. [Срок оценки: Week 4, Week 8, Week 16 and Week 20.]

Критерии участия

Критерии включения

• Age ≥ 18 years old, without infectious diseases such as "hepatitis B" and "tuberculosis" and major underlying diseases (gender not limited);

• "Outpatient Diagnosis" includes "primary cutaneous amyloidosis", "macular amyloidosis" or "lichen amyloidosis";

• Visited the outpatient department for PCA treatment for 4 times or more;

• The medication record shows "Avastin Capsules" and/or "Tofacitinib Citrate";

• The medical record fully records baseline characteristics, medication dosage, efficacy assessment and adverse events.

Критерии исключения

• Nodular amyloidosis or combined with other types of amyloidosis (such as systemic amyloidosis);

• During the study period, other immunosuppressants (such as glucocorticoids, methotrexate) or biologics were used;

• Incomplete medical records such as demographic data, laboratory parameters, prescription administration and patient prognosis, as well as irregular treatment, etc.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Med — Чунцин

Идентификаторы

NCT: NCT06998875 · KY2025060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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