Tofacitinib plus acitretin versus acitretin alone for primary cutaneous amyloidosis

A Prospective 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

This tests whether adding tofacitinib to acitretin helps adults with primary cutaneous amyloidosis and relieves itch faster than acitretin alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Army Medical University, China (Academic / other)
• Drugs / interventions: Tofacitinib, methotrexate, tocilizumab
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06998875 on ClinicalTrials.gov

What this trial studies

This is a Phase 4, prospective interventional cohort comparing combination therapy (tofacitinib plus acitretin) with acitretin alone in adults with primary cutaneous amyloidosis. Participants receive either the combination or acitretin monotherapy and are followed with regular outpatient visits to measure pruritus scores and monitor adverse events. The trial excludes nodular or systemic amyloidosis and concurrent use of other immunosuppressants or biologics, and requires reasonably complete prior medical records. The primary outcomes focus on speed and degree of itch relief and safety/tolerability of the combination regimen at a single dermatology center in Chongqing, China.

Who should consider this trial

Good fit: Adults aged 18 or older with a clinical outpatient diagnosis of primary cutaneous amyloidosis (macular or lichen type) who can attend regular visits and have adequate medical records are ideal candidates.

Not a fit: Patients with nodular or systemic amyloidosis, those using other immunosuppressants/biologics, or those with incomplete records or major uncontrolled comorbidities are unlikely to benefit from joining this protocol.

Why it matters

Potential benefit: If successful, the combination could reduce itch faster and improve symptom control for people with primary cutaneous amyloidosis without unacceptable side effects.

How similar studies have performed: There are limited case reports and small series suggesting JAK inhibitors can help pruritic skin diseases, but combining tofacitinib with acitretin for primary cutaneous amyloidosis is relatively novel and not well established.

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.

Where this trial is running

Chongqing, Chongqing Municipality

• Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Rui Yin, MD — Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
• Study coordinator: Rui Yin, MD

Conditions Primary Cutaneous Amyloidosis