Actively Recruiting
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
Led by Army Medical University, China · Updated on 2025-08-13
56
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No infectious diseases such as hepatitis B or tuberculosis
- No major underlying diseases
- Diagnosis of primary cutaneous amyloidosis, macular amyloidosis, or lichen amyloidosis
- At least four outpatient visits for primary cutaneous amyloidosis treatment
- Medication records showing use of Avastin Capsules and/or Tofacitinib Citrate
- Complete medical records including baseline characteristics, medication dosage, efficacy assessment, and adverse events
You will not qualify if you...
- Nodular amyloidosis or presence of other types of amyloidosis such as systemic amyloidosis
- Use of other immunosuppressants (e.g., glucocorticoids, methotrexate) or biologics during the study
- Incomplete medical records or irregular treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
Research Team
R
Rui Yin, MD
CONTACT
S
Shiyu Lin, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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