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Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

Primary Purpose

Psoriasis Vulgaris

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Acitretin Capsules

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed according to Classification criteria for Psoriasis vulgaris
Patients aged 18 to 70 years (to the date of screening)
PASI grade ≥7point
Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.
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
Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria:

Pregnant women, ready to pregnant or lactating women
Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
Patients with chronic diarrhea, or peptic ulcer nearly 1 year
Patients suffering from malignant tumor
Patients suffering from acute and chronic infectious diseases
Mental disorders, history of alcohol abuse, drug or other substance abuse
Other cases which researchers believe that can not enroll

Sites / Locations

Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

intervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece.

Outcomes

Primary Outcome Measures

disease control rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02715960

First Posted

March 17, 2016

Last Updated

March 21, 2016

Sponsor

Central South University

1. Study Identification

Unique Protocol Identification Number

NCT02715960

Brief Title

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

Official Title

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central South University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single-arm

Arm Type

Experimental

Arm Description

intervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece.

Intervention Type

Drug

Intervention Name(s)

Acitretin Capsules

Other Intervention Name(s)

Tretinoin, Vitamine A Acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

disease control rate

Time Frame

8 weeks after the first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed according to Classification criteria for Psoriasis vulgaris Patients aged 18 to 70 years (to the date of screening) PASI grade ≥7point Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled. 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 Understanding the whole process of the study, voluntary participation and signed the informed consent Exclusion Criteria: Pregnant women, ready to pregnant or lactating women Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers Patients with chronic diarrhea, or peptic ulcer nearly 1 year Patients suffering from malignant tumor Patients suffering from acute and chronic infectious diseases Mental disorders, history of alcohol abuse, drug or other substance abuse Other cases which researchers believe that can not enroll

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yijing He, PhD,MD

Phone

+86-1587481262

yijinghe@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiang Chen, MD

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangya Hospital Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yijing He, MD, PhD

Phone

+86-1587481262

yijinghe@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

data not entered

Learn more about this trial

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

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