Overview
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules
Status:
Unknown status
Unknown status
Trial end date:
2017-12-01
2017-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Central South UniversityTreatments:
Acitretin
Tretinoin
Vitamin A
Criteria
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