A Prospective Cohort Study on Primary Cutaneous Amyloidosis
ConditionPrimary Cutaneous Amyloidosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorArmy Medical University, China
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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";
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Tofacitinib and Acitretin Capsules.
DrugThe same with Arms.
Acitretin Capsules.
DrugThe same with Arms.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0, Week 4, Week 8, Week 12 and Week 16.Secondary outcomes
1
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.
Time frame
Week 0, Week 4, Week 8, Week 12 and Week 16.2
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.
Time frame
Week 0, Week 4, Week 8, Week 12 and Week 16.3
DLQI.
DLQI (Dermatology Life Quality Index) ranges from 0 to 30, and the higher the score, the greater the impact on daily life.
Time frame
Week 0, Week 4, Week 8, Week 12 and Week 16.4
ISI.
ISI (Insomnia Severity Index) ranges from 0 to 28, and the higher the score, the more severe the degree of insomnia.
Time frame
Week 0, Week 4, Week 8, Week 12 and Week 16.Sponsors and contacts
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Source ClinicalTrials.gov