NCT06998875RecruitingPhase 4
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
A Prospective Cohort Study on the Efficacy and Safety Comparison of Tofacitinib Citrate Tablets Combined With Acitretin Capsules Versus Acitretin Capsules Alone in the Treatment of Primary Cutaneous Amyloidosis
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 13 Apr 2025
- Start date
- 1 Mar 2025
- Primary completion date
- Oct 2025
- Lead sponsor
- Army Medical University, China
- Diseases
- Amyloidosis
- NCT number
- NCT06998875
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 56
- From 1 Mar 2025 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.