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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
The same with Arms.
The same with Arms.
Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, China
RECRUITINGVisual 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.
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.
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.
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.
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.
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.
Time frame: Up to 8 weeks.
Recurrence rate.
Within 24 weeks after the treatment concludes, check whether the participants have any recurrence of the disease.
Time frame: Within 24 weeks after the treatment concludes.
Incidence rate of adverse events.
Liver or kidney function impairment; Abnormal lipid metabolism; Abnormal thyroid function, etc.
Time frame: Week 4, Week 8, Week 16 and Week 20.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.