A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Recruiting now · Phase 4

Conditions studied: Primary Cutaneous Amyloidosis

In brief

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.

Key facts

Study ID: NCT06998875
Run by: Army Medical University, China
People needed: 56
Starts: 2025-03-01
Expected to finish: 2025-12-01
Last updated by the study team: 2025-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) — Chongqing, Chongqing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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