A Prospective Cohort Study on Primary Cutaneous Amyloidosis

NCT ID: NCT06998875

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Primary Cutaneous Amyloidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tofacitinib and Acitretin Capsules.

Intervention Type: DRUG

The same with Arms.

Control group

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

Group Type: ACTIVE_COMPARATOR

Acitretin Capsules.

Intervention Type: DRUG

The same with Arms.

Interventions

Tofacitinib and Acitretin Capsules.

The same with Arms.

Intervention Type: DRUG

Acitretin Capsules.

The same with Arms.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Army Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Rui Yin

Professor/Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Yin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)

Locations

Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Yin, MD

Role: CONTACT

swyinrui@tmmu.edu.cn

15823265888 ext. 15823265888

Shiyu Lin, MS

Role: CONTACT

linshiyu@tmmu.edu.cn

15922662986

Facility Contacts

Rui Yin, MD

Role: primary

swyinrui@tmmu.edu.cn

15823265888

Shiyu Lin, MS

Role: backup

linshiyu@tmmu.edu.cn

15922662986

Other Identifiers

KY2025060

Identifier Type: -

Identifier Source: org_study_id