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NCT Number: NCT06998875

A Prospective Cohort Study on Primary Cutaneous Amyloidosis

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. 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. 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:

1. Take the combination of tocilizumab tablets and acitretin capsules or acitretin capsules alone every day for 16 weeks. 2. Visit the clinic once every 4 weeks for checkups and tests. 3. Observe participants at 4 weeks, 12 weeks and 24 weeks after discontinuation of medication to determine the recurrence status. 4. 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.

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Key information

Conditions

Primary Cutaneous Amyloidosis Amyloidosis, Primary Cutaneous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Chongqing, Chongqing Municipality, 400038, China

Location status: Recruiting

Location contact

Rui Yin, MD

CONTACT

[email protected]

15823265888

Shiyu Lin, MS

CONTACT

[email protected]

15922662986

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tofacitinib and Acitretin Capsules.

Drug

The same with Arms.

Acitretin Capsules.

Drug

The same with Arms.

Primary outcomes

  1. Visual analogue scale (VAS) scores for pruritus.

    Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.

    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.

Secondary outcomes

  1. SCORAD index.

    Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.

    SCORAD (Scoring Atopic Dermatitis) Index ranges from 0 to 83, which is used to describe symptoms and signs, and the higher the csore, the more severe the disease.

  2. EASI Index.

    Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.

    EASI (Eczema area and severity) Index ranges from 0 to 72, which is used to describe the area and severity of the rash and the treatment response, and the higher the score, the larger the area and severity of the rash, and the worse the treatment response.

  3. DLQI.

    Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.

    DLQI (Dermatology Life Quality Index) ranges from 0 to 30, and the higher the score, the greater the impact on daily life.

  4. ISI.

    Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.

    ISI (Insomnia Severity Index) ranges from 0 to 28, and the higher the score, the more severe the degree of insomnia.

  5. The onset time of drug efficacy.

    Time frame: Up to 8 weeks.

    When the participants return for follow-up visit, the time elapsed from the moment the participants first started taking the medicine to the point when the symptoms have alleviated or disappeared is calculated.

  6. Recurrence rate.

    Time frame: Within 24 weeks after the treatment concludes.

    Within 24 weeks after the treatment concludes, check whether the participants have any recurrence of the disease.

  7. Incidence rate of adverse events.

    Time frame: Week 4, Week 8, Week 16 and Week 20.

    Liver or kidney function impairment; Abnormal lipid metabolism; Abnormal thyroid function, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui Yin, MD

CONTACT

[email protected]

15823265888 ext. 15823265888

Shiyu Lin, MS

CONTACT

[email protected]

15922662986

Sponsors and collaborators

Lead sponsor

Army Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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