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A retrospective cohort study on the efficacy and safety comparison of tofacitinib citrate tablets combined with acitretin capsules and acitretin capsules alone in the treatment of primary cutaneous amyloidosis

A retrospective cohort study on the efficacy and safety comparison of tofacitinib citrate tablets combined with acitretin capsules and acitretin capsules alone in the treatment of primary cutaneous amyloidosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124084
Enrollment
Unknown
Registered
2026-05-07
Start date
2025-04-10
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary cutaneous amyloidosis

Interventions

Observation group(Tofacitinib citrate tablets combined with acitretin capsules):None
Control group(acitretin capsules):None

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old, free from infectious diseases such as hepatitis B and tuberculosis and major underlying diseases (gender not limited); 2.The outpatient diagnosis includes "primary cutaneous amyloidosis" or "macular amyloidosis" or "lichen amyloidosis"; 3.Because PCA has visited the clinic 4 times or more; 4.The medication record shows "Avita Capsules" and/or "Tofacitinib Citrate"; 5.The medical record comprehensively records the baseline characteristics, dosage of medication, efficacy assessment, and adverse events.

Exclusion criteria

Exclusion criteria: 1.Nodular amyloidosis or combined with other types of amyloidosis (such as systemic amyloidosis); 2.During the study period, other immunosuppressants (such as glucocorticoids, methotrexate) or biologics were used; 3.The medical records, including demographic data, laboratory parameters, prescription administration, and the patient's prognosis, are incomplete, and the treatment was not standardized.

Design outcomes

Primary

MeasureTime frame
The composite clinical response rate for the 12th week;

Secondary

MeasureTime frame
Recurrent rate in the 24th week;Incidence rate of adverse events;Change in the area of skin lesions;Changes in peak pruritus scores at different time points;Achieve an IGA 0/1 (complete or nearly complete) ratio;

Countries

China

Contacts

Public ContactYin Rui

The First Affiliated Hospital of Army Medical University

swyinrui@163.com+86 23 68766333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026