Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

NCT02715960 | Unknown Phase 2 DMC

• 1 other identifier: 2016 AW/CSU/PS
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• disease control rate

  8 weeks after the first treatment

Study Arms (1)

single-arm

EXPERIMENTAL

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

Drug: Acitretin Capsules

Interventions

Acitretin Capsules DRUG

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.

Also known as: Tretinoin, Vitamine A Acid

single-arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Interventions

Acitretin; Tretinoin

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors; Vitamin A; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes

Study Officials

• Xiang Chen, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yijing He, PhD,MD

CONTACT

+86-1587481262; yijinghe@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2016

Record last verified: 2015-12

Locations

CN (1)