Tofacitinib plus acitretin versus acitretin alone for primary cutaneous amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: swyinrui@tmmu.edu.cn
• Phone: 15823265888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

  This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.

  Recruiting Phase 1 AbbVie · Grayslake, Illinois · NCT07843693

• Heart event risk in people with moderate-to-severe rheumatoid arthritis taking tofacitinib plus a statin versus TNF inhibitors.

  This will test whether taking tofacitinib with a daily statin changes the rate of major heart problems in people 50 and older with moderate-to-severe rheumatoid arthritis and at least one cardiovascular risk factor.

  Recruiting Phase 4 Shaikh Zayed Hospital, Lahore · Lahore, Punjab Province · NCT07554820

• Tofacitinib for steroid‑resistant moderate-to-severe thyroid eye disease

  This will test whether taking oral tofacitinib (5 mg twice daily) for 24 weeks can reduce eye bulging and inflammation in adults with moderate-to-severe thyroid eye disease who don't respond to or cannot take high-dose steroids.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07547930

• Topical anti-inflammatory plus yellow light with tofacitinib and doxycycline for mild to moderate erythematotelangiectatic rosacea

  This trial will try combining a topical anti-inflammatory regimen (Hirudoid followed by yellow light therapy) with the oral medicines tofacitinib and doxycycline to see if it helps Chinese adults with mild to moderate erythematotelangiectatic rosacea.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT07343635

• Tofacitinib safety for people with primary Sjogren disease

  This study will test whether the oral pill tofacitinib is safe and tolerable for adults with primary Sjogren disease and mild-to-moderate symptoms.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07281456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.