Psoriasis Vulgaris
Conditions
Brief summary
In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.
Detailed description
Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.
Interventions
During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.
Sponsors
Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed according to Classification criteria for Psoriasis vulgaris 2. Patients aged 18 to 70 years (to the date of screening) 3. PASI grade ≥7point 4. Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled. 5. Total bilirubin \< 1.5 x ULN, AST(SGOT)/ALT(SGPT) \<2.5 x ULN if not liver metastases\<5 x ULN if known liver metastases, Creatinine clearance \<1.5 x ULN 6. Understanding the whole process of the study, voluntary participation and signed the informed consent
Exclusion criteria
1. Pregnant women, ready to pregnant or lactating women 2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history 3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers 4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year 5. Patients suffering from malignant tumor 6. Patients suffering from acute and chronic infectious diseases 7. Mental disorders, history of alcohol abuse, drug or other substance abuse 8. Other cases which researchers believe that can not enroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | 8 weeks after the first treatment |
Countries
China
Contacts
Primary ContactYijing He, PhD,MD
Outcome results
None listed