A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Army Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 4

Conditions: Primary Cutaneous Amyloidosis

Treatments: Drug: Tofacitinib and Acitretin Capsules.; Drug: Acitretin Capsules.

Study type: Interventional

Funder types: Other

Identifiers

NCT06998875

KY2025060

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Tofacitinib and Acitretin Capsules.

Control group

Active Comparator group

Description:

Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous course of 16 weeks.

Treatment:

Drug: Acitretin Capsules.