Clinical trial NCT04414605: Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis
Official title: Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Psoriasis
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.

Detailed description: The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.

Eligibility criteria: Inclusion Criteria:

1. Psoriasis Area and Severity Index (PASI) score≥10
2. Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
3. Written/signed informed consent

Exclusion Criteria:

1. Unsuitable for the treatment of secukinumab

Primary outcomes:
measure: Median time to relapse
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI) score
timeFrame: Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year
measure: PASI-75
timeFrame: 16 weeks after treatment
measure: PASI-90
timeFrame: 16 weeks after treatment
measure: Physician's global assessment (PGA) score
timeFrame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
measure: Pruritus Scores on the Visual Analogue Scale
timeFrame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
measure: BSA
timeFrame: Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
measure: Skindex16
timeFrame: Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
measure: patients' attitudes, expectation and experience
timeFrame: Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Chuanjian Lu, PhD
role: PRINCIPAL_INVESTIGATOR
References: