Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03372811
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Psoriasis Research Institute of Guangzhou

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

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: TC cream Drug: Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double
Primary Purpose: Treatment
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.
Actual Study Start Date : June 11, 2015
Actual Primary Completion Date : March 14, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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

Placebo Comparator: Vehicle Drug: Vehicle
Vehicle




Primary Outcome Measures :
  1. Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions [ Time Frame: up to 12 weeks ]
    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 :
  1. Change in Psoriasis Area and Severity Index (PASI) scores [ Time Frame: up to 12 weeks ]
    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)

  2. Change in Dermatology Life Quality Index (DLQI) scores [ Time Frame: up to 12 weeks ]
    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.

  3. Change in Psoriasis Disability Index questionnaire (PDI) scores [ Time Frame: up to 12 weeks ]
    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.


Other Outcome Measures:
  1. Drug-related incidence and severity of adverse events [ Time Frame: week 8 ]
    Percentage of patients with incidence and adverse events related to treatment

  2. Percentage of patients with drug-related changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Urinalysis laboratory assessments

  3. Percentage of patients with abnormal changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Biochemistry laboratory assessments

  4. Percentage of patients with drug-related changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Hematology and coagulation laboratory assessments

  5. Percentage of patients with drug-related changes in physical examination from baseline related to treatment [ Time Frame: week 8 and week 12 ]
    Systolic/diastolic blood pressure assessments

  6. Percentage of patients with drug-related changes in physical examination from baseline related to treatment [ Time Frame: week 8 and week 12 ]
    Pulse rate assessments

  7. Percentage of patients with drug-related changes in physical examination from baseline related to treatment [ Time Frame: week 8 and week 12 ]
    Respiration rate assessments

  8. Percentage of patients with drug-related changes in physical examination from baseline related to treatment [ Time Frame: week 8 and week 12 ]
    Body temperature assessments

  9. Percentage of patients with drug-related changes in liver functions from baseline [ Time Frame: week 8 ]
    Laboratory assessments of liver functions

  10. Percentage of patients with drug-related changes in renal functions from baseline [ Time Frame: week 8 ]
    Laboratory assessments of renal functions

  11. Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline [ Time Frame: week 8 ]
    Assessments of PR/PQ intervals, QRS duration and QT intervals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372811


Locations
Layout table for location information
United States, New York
Department of Dermatology, State University of New York, Downstate Medical Center
New York, New York, United States, 11203
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Psoriasis Research Institute of Guangzhou
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Psoriasis Research Institute of Guangzhou
ClinicalTrials.gov Identifier: NCT03372811     History of Changes
Other Study ID Numbers: 105883-1
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases