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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TC cream
Vehicle
Sponsored by
Psoriasis Research Institute of Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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.

Sites / Locations

  • Department of Dermatology, State University of New York, Downstate Medical Center
  • Dermatology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TC cream (10%)

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
November 30, 2017
Last Updated
May 15, 2019
Sponsor
Psoriasis Research Institute of Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT03372811
Brief Title
Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2015 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Research Institute of Guangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

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
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TC cream (10%)
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TC cream
Intervention Description
A well-characterized botanical drug for topical treatment of psoriasis vulgaris
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) scores
Description
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)
Time Frame
up to 12 weeks
Title
Change in Dermatology Life Quality Index (DLQI) scores
Description
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.
Time Frame
up to 12 weeks
Title
Change in Psoriasis Disability Index questionnaire (PDI) scores
Description
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.
Time Frame
up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Drug-related incidence and severity of adverse events
Description
Percentage of patients with incidence and adverse events related to treatment
Time Frame
week 8
Title
Percentage of patients with drug-related changes in clinical laboratory results from baseline
Description
Urinalysis laboratory assessments
Time Frame
week 8
Title
Percentage of patients with abnormal changes in clinical laboratory results from baseline
Description
Biochemistry laboratory assessments
Time Frame
week 8
Title
Percentage of patients with drug-related changes in clinical laboratory results from baseline
Description
Hematology and coagulation laboratory assessments
Time Frame
week 8
Title
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Description
Systolic/diastolic blood pressure assessments
Time Frame
week 8 and week 12
Title
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Description
Pulse rate assessments
Time Frame
week 8 and week 12
Title
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Description
Respiration rate assessments
Time Frame
week 8 and week 12
Title
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Description
Body temperature assessments
Time Frame
week 8 and week 12
Title
Percentage of patients with drug-related changes in liver functions from baseline
Description
Laboratory assessments of liver functions
Time Frame
week 8
Title
Percentage of patients with drug-related changes in renal functions from baseline
Description
Laboratory assessments of renal functions
Time Frame
week 8
Title
Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline
Description
Assessments of PR/PQ intervals, QRS duration and QT intervals
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Heilman, MD
Organizational Affiliation
Department of Dermatology, State University of New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J. Jenkin, MD
Organizational Affiliation
Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiang Yang, Ph.D.
Organizational Affiliation
Psoriasis Research Institute of Guangzhou
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liping Yang, MD
Organizational Affiliation
Psoriasis Research Institute of Guangzhou
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Dermatology, State University of New York, Downstate Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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