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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous period of 16 weeks; at the same time, take Tofactinib tablets, 5mg each time, twice a day, for a continuous period of 16 weeks. |
|
| Control group | Active Comparator | Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous course of 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib and Acitretin Capsules. | Drug | The same with Arms. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) scores for pruritus. | The average percentage changes in the visual analogue scale (VAS) scores for pruritus from baseline to Week 4, 8, 12 and 16 after medication administration. VAS score for pruritus ranges from 0 to 10, and the higher the score, the worse the outcome. | Week 0, Week 4, Week 8, Week 12 and Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| SCORAD index. | SCORAD (Scoring Atopic Dermatitis) Index ranges from 0 to 83, which is used to describe symptoms and signs, and the higher the csore, the more severe the disease. | Week 0, Week 4, Week 8, Week 12 and Week 16. |
| EASI Index. |
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Inclusion Criteria:
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";
Exclusion Criteria:
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Yin, MD | Contact | 15823265888 | 15823265888 | swyinrui@tmmu.edu.cn |
| Shiyu Lin, MS | Contact | 15922662986 | linshiyu@tmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rui Yin, MD | Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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| ID | Term |
|---|---|
| C562642 | Amyloidosis, Primary Cutaneous |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Acitretin Capsules. |
| Drug |
The same with Arms. |
|
EASI (Eczema area and severity) Index ranges from 0 to 72, which is used to describe the area and severity of the rash and the treatment response, and the higher the score, the larger the area and severity of the rash, and the worse the treatment response.
| Week 0, Week 4, Week 8, Week 12 and Week 16. |
| DLQI. | DLQI (Dermatology Life Quality Index) ranges from 0 to 30, and the higher the score, the greater the impact on daily life. | Week 0, Week 4, Week 8, Week 12 and Week 16. |
| ISI. | ISI (Insomnia Severity Index) ranges from 0 to 28, and the higher the score, the more severe the degree of insomnia. | Week 0, Week 4, Week 8, Week 12 and Week 16. |
| The onset time of drug efficacy. | When the participants return for follow-up visit, the time elapsed from the moment the participants first started taking the medicine to the point when the symptoms have alleviated or disappeared is calculated. | Up to 8 weeks. |
| Recurrence rate. | Within 24 weeks after the treatment concludes, check whether the participants have any recurrence of the disease. | Within 24 weeks after the treatment concludes. |
| Incidence rate of adverse events. | Liver or kidney function impairment; Abnormal lipid metabolism; Abnormal thyroid function, etc. | Week 4, Week 8, Week 16 and Week 20. |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |