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A Prospective Cohort Study on Primary Cutaneous Amyloidosis

NCT06998875 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-08-13

No results posted yet for this study

Summary

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

  • Primary Cutaneous Amyloidosis

Interventions

DRUG

Tofacitinib and Acitretin Capsules.

The same with Arms.

DRUG

Acitretin Capsules.

The same with Arms.

Sponsors & Collaborators

  • Army Medical University, China

    lead OTHER

Principal Investigators

  • Rui Yin, MD · Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998875 on ClinicalTrials.gov