Primary Cutaneous AmyloidosisPhase 4NCT06998875
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
A Phase 4 study testing Tofacitinib and Acitretin Capsules. and Acitretin Capsules. in people with Primary Cutaneous Amyloidosis, run by Army Medical University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Cutaneous Amyloidosis
- What is being tested?
- Tofacitinib and Acitretin Capsules. and Acitretin Capsules.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038
Rui Yin, MD, 15823265888, swyinrui@tmmu.edu.cn
Shiyu Lin, MS, 15922662986, linshiyu@tmmu.edu.cn
About this study
Official 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
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.
Read more
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.
- Conditions
- Primary Cutaneous Amyloidosis
- Being tested
- Tofacitinib and Acitretin Capsules., Acitretin Capsules.
- Medical subject headings
- Amyloidosis, Primary Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib and Acitretin Capsules.Drug
The same with Arms.
Acitretin Capsules.Drug
The same with Arms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous period of 16 weeks; at the same time, take Tofactinib tablets, 5mg each time, twice a day, for a continuous period of 16 weeks. Receives: Drug: Tofacitinib and Acitretin Capsules. |
| Control group | Active comparator | Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous course of 16 weeks. Receives: Drug: Acitretin Capsules. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) scores for pruritus.
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.
Measured: Week 0, Week 4, Week 8, Week 12 and Week 16.
Secondary outcomes (7)
SCORAD index.
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.
Measured: Week 0, Week 4, Week 8, Week 12 and Week 16.
EASI Index.
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.
Measured: Week 0, Week 4, Week 8, Week 12 and Week 16.
DLQI.
DLQI (Dermatology Life Quality Index) ranges from 0 to 30, and the higher the score, the greater the impact on daily life.
Measured: Week 0, Week 4, Week 8, Week 12 and Week 16.
ISI.
ISI (Insomnia Severity Index) ranges from 0 to 28, and the higher the score, the more severe the degree of insomnia.
Measured: Week 0, Week 4, Week 8, Week 12 and Week 16.
The onset time of drug efficacy.
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.
Measured: Up to 8 weeks.
Recurrence rate.
Within 24 weeks after the treatment concludes, check whether the participants have any recurrence of the disease.
Measured: Within 24 weeks after the treatment concludes.
Incidence rate of adverse events.
Liver or kidney function impairment; Abnormal lipid metabolism; Abnormal thyroid function, etc.
Measured: Week 4, Week 8, Week 16 and Week 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Mar 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cutaneous AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yin, Army Medical University, China
- Investigators
- Rui Yin, MD, Principal investigator, Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998875
- Sponsor's protocol ID
- KY2025060
- Status last verified
- Aug 2025
- First submitted
- 13 Apr 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06998875
- Acronym / sponsor ID
- KY2025060
- Conditions
- Primary Cutaneous Amyloidosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Tofacitinib and Acitretin Capsules.Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous period of 16 weeks; at the same time, take Tofactinib tablets, 5mg each time, twice a day, for a continuous period of 16 weeks. |
| Control group | Active comparator | Drug: Acitretin Capsules.Take oral Acitretin capsules, 10mg each time, twice a day, for a continuous course of 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old, without infectious diseases such as "hepatitis B" and "tuberculosis" and major underlying diseases (gender not limited);
Key exclusion criteria (3 listed)
- Nodular amyloidosis or combined with other types of amyloidosis (such as systemic amyloidosis);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib and Acitretin Capsules.The same with Arms. | Drug | Experimental group |
| Acitretin Capsules.The same with Arms. | Drug | Control group |
Primary outcome
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.
7 secondary outcomes
SCORAD index.
Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.
EASI Index.
Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.
DLQI.
Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.
ISI.
Time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.
The onset time of drug efficacy.
Time frame: Up to 8 weeks.
Recurrence rate.
Time frame: Within 24 weeks after the treatment concludes.
Incidence rate of adverse events.
Time frame: Week 4, Week 8, Week 16 and Week 20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rui Yin, MD principal investigator
Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tofacitinib and Acitretin Capsules. and Acitretin Capsules. in people with Primary Cutaneous Amyloidosis, run by Army Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Yin, MD (15823265888 ext. 15823265888, swyinrui@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) scores for pruritus. (time frame: Week 0, Week 4, Week 8, Week 12 and Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.