A Prospective Cohort Study on Primary Cutaneous Amyloidosis

NCT06998875 | Recruiting Phase 4

• 1 other identifier: KY2025060
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.Take the combination of tocilizumab tablets and acitretin capsules or acitretin capsules alone every day for 16 weeks.
4. 4.Visit the clinic once every 4 weeks for checkups and tests.
5. 5.Observe participants at 4 weeks, 12 weeks and 24 weeks after discontinuation of medication to determine the recurrence status.
6. 6.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

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) scores for pruritus.

  The average percentage changes in the visual analogue scale (VAS) scores for pruritus from baseline to Week 4, 8, 12 and 16 after medication administration. VAS score for pruritus ranges from 0 to 10, and the higher the score, the worse the outcome.

  Week 0, Week 4, Week 8, Week 12 and Week 16.

Secondary Outcomes (7)

• SCORAD index.

  Week 0, Week 4, Week 8, Week 12 and Week 16.

• EASI Index.

  Week 0, Week 4, Week 8, Week 12 and Week 16.

• DLQI.

  Week 0, Week 4, Week 8, Week 12 and Week 16.

• ISI.

  Week 0, Week 4, Week 8, Week 12 and Week 16.

• The onset time of drug efficacy.

  Up to 8 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Tofacitinib and Acitretin Capsules.

Control group

ACTIVE COMPARATOR

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

Drug: Acitretin Capsules.

Interventions

Tofacitinib and Acitretin Capsules. DRUG

The same with Arms.

Experimental group

Acitretin Capsules. DRUG

The same with Arms.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Army Medical University, China: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Amyloidosis, Primary Cutaneous

Interventions

tofacitinib; Acitretin

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Rui Yin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Yin, MD

CONTACT

15823265888; swyinrui@tmmu.edu.cn

Shiyu Lin, MS

CONTACT

15922662986; linshiyu@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Chief Physician

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 31, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)