ClinicalTrials.gov record NCT06998875

A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a randomized, quadruple-masked Phase 4 trial testing whether adding tofacitinib to acitretin changes symptoms and safety outcomes in people with primary cutaneous amyloidosis. Participants take study medication daily for 16 weeks, attend clinic visits every 4 weeks, and are followed for recurrence up to 24 weeks after stopping. Primary and secondary outcomes include itch scores, skin severity scores, quality of life, sleep, and adverse events.

What it is studying. The study tests the effects and safety of combining tofacitinib tablets with acitretin capsules versus taking acitretin capsules alone in people with primary cutaneous amyloidosis. The main measurement is change in itch using a visual analogue scale (VAS) at baseline and at planned visits through Week 16. Other measurements include skin severity scores (SCORAD, EASI), dermatology quality of life (DLQI), insomnia severity (ISI), time to symptom improvement, recurrence within 24 weeks after treatment, and rates of adverse events (including liver/kidney changes, lipid and thyroid abnormalities).

What the researchers hope to learn. To learn whether adding tofacitinib to acitretin changes itch severity over time and to compare safety profiles between the combination and acitretin alone. To collect data on skin severity (SCORAD, EASI), quality of life (DLQI), sleep (ISI), time to symptom improvement, recurrence rates within 24 weeks after treatment, and incidence of adverse events (including liver or kidney function changes, lipid and thyroid abnormalities).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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:

  • 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?
  • 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:

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Tofacitinib and Acitretin Capsules.
  • Acitretin Capsules.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take assigned oral study medicine daily for 16 weeks: either acitretin 10 mg twice daily plus tofacitinib 5 mg twice daily, or acitretin 10 mg twice daily alone. They come to the clinic about once every 4 weeks for checkups and tests and complete symptom and quality-of-life questionnaires (for example itch VAS, SCORAD, EASI, DLQI, ISI) at baseline and during treatment. After stopping medication, participants are observed for recurrence at about 4, 12 and 24 weeks. Study staff will also monitor and record any adverse events during and shortly after treatment.

How the study is structured. Interventional, randomized, parallel-group Phase 4 trial. Participants are randomly assigned to one of two groups: acitretin alone or acitretin plus tofacitinib. Treatment is taken daily for 16 weeks. The study is quadruple-masked (participant, care provider, investigator, and outcomes assessor). Clinic visits and outcome assessments occur every 4 weeks during treatment, with additional follow-up checks after treatment to assess recurrence.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Primary Cutaneous Amyloidosis. Does it apply to my diagnosis?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2025
Primary completion
October 2025 (estimated)
Study completion
December 2025 (estimated)
Target enrollment
56 participants (estimated)
Last updated on registry
Aug 13, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Army Medical University, China
Principal investigator
Rui Yin, Professor/Chief Physician
Army Medical University, China

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
glucocorticoids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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