Clinical trial NCT06998875: A Retrospective Cohort Study on Primary Cutaneous Amyloidosis
Official title: A Retrospective 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Cutaneous Amyloidosis
Lead sponsor: Army Medical University, China
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual analogue scale (VAS) scores for pruritus.
timeFrame: Week 0, Week 4, Week 8, Week 12 and Week 16.
Secondary outcomes:
measure: SCORAD index.
timeFrame: Week 0, Week 4, Week 8, Week 12 and Week 16.
measure: EASI Index.
timeFrame: Week 0, Week 4, Week 8, Week 12 and Week 16.
measure: DLQI.
timeFrame: Week 0, Week 4, Week 8, Week 12 and Week 16.
measure: ISI.
timeFrame: Week 0, Week 4, Week 8, Week 12 and Week 16.
measure: The onset time of drug efficacy.
timeFrame: Up to 8 weeks.
measure: Recurrence rate.
timeFrame: Within 24 weeks after the treatment concludes.
measure: Incidence rate of adverse events.
timeFrame: Week 4, Week 8, Week 16 and Week 20.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
state: Chongqing
Study officials:
affiliation: Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
name: Rui Yin, MD
role: PRINCIPAL_INVESTIGATOR
References: