Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris.

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with Psoriasis Vulgaris

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Vehicle; Drug: TC cream

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11203
      • Department of Dermatology, State University of New York, Downstate Medical Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age of 18-70 years old. Both men and women and members of all races and ethnic groups
• Consistent with diagnostic criteria of stable phase psoriasis vulgaris and have at least two target lesions suitable for evaluation
• Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
• ISGA score ≥ 2 (at least mild severity)
• BSA (stable stage group): 1%≤ to ≤20%
• Signed a written informed consent document
• No additional exposure to the sun

Exclusion Criteria:

• Subjects in pregnancy, preparing for pregnancy or breast feeding
• History of hyperergic or photosensitivity
• History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of hepatic, kidney and hematopoietic system, or patients with psychiatric disorders
• History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa

• Within 4 weeks prior to randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:

  • Topical treatments
  • PUVA, UVB or Grenz ray therapy.
  • Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
  • Any types of other investigational therapies for psoriasis
• Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab).
• Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle; Vehicle
Active Comparator: TC cream (10%)	Drug: TC cream; A well-characterized botanical drug for topical treatment of psoriasis vulgaris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions	ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psoriasis Area and Severity Index (PASI) scores	PASI is the most extensively used tool to measure severity of psoriasis by combing the severity of lesions (erythema, induration and desquamation) and affected area into one single score. Scale ranges from 0 (no disease) to 72 (maximal disease)	up to 12 weeks
Change in Dermatology Life Quality Index (DLQI) scores	DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life.	up to 12 weeks
Change in Psoriasis Disability Index questionnaire (PDI) scores	PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life.	up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug-related incidence and severity of adverse events	Percentage of patients with incidence and adverse events related to treatment	week 8
Percentage of patients with drug-related changes in clinical laboratory results from baseline	Urinalysis laboratory assessments	week 8
Percentage of patients with abnormal changes in clinical laboratory results from baseline	Biochemistry laboratory assessments	week 8
Percentage of patients with drug-related changes in clinical laboratory results from baseline	Hematology and coagulation laboratory assessments	week 8
Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Systolic/diastolic blood pressure assessments	week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Pulse rate assessments	week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Respiration rate assessments	week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Body temperature assessments	week 8 and week 12
Percentage of patients with drug-related changes in liver functions from baseline	Laboratory assessments of liver functions	week 8
Percentage of patients with drug-related changes in renal functions from baseline	Laboratory assessments of renal functions	week 8
Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline	Assessments of PR/PQ intervals, QRS duration and QT intervals	week 8

Collaborators and Investigators

• Sponsor: Psoriasis Research Institute of Guangzhou
• Investigators: Principal Investigator: Edward Heilman, MD, Department of Dermatology, State University of New York; Principal Investigator: Peter J. Jenkin, MD, Dermatology Associates; Study Director: Jiang Yang, Ph.D., Psoriasis Research Institute of Guangzhou; Study Chair: Liping Yang, MD, Psoriasis Research Institute of Guangzhou

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 105883-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No