A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Sponsor
Army Medical University, China
Study ID
NCT06998875
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Primary Cutaneous Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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 Dates

Start date
Mar 1, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    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.
  • Active Comparator: Control group
    Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous course of 16 weeks.

Primary Outcome Measure

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

Central Contacts