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

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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

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE June 11, 2015
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Change in ISGA (Investigator's Static Global Assessment Scale) scores of target lesions [ Time Frame: up to 12 weeks ]
A 6-point ordinal scale is used for estimation ranging from 0-5 representing completely clear to very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
Change History Complete list of historical versions of study NCT03372811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Change in PASI (Psoriasis Area and Severity Index) scores [ Time Frame: up to 12 weeks ]
    Scale from 0 (no disease) to 72 (maximal disease)
  • Change in DLQI (Dermatology Life Quality Index ) scores [ Time Frame: up to 12 weeks ]
    DLQI scale from 0 to 30 with lower scores associated with a better quality of life
  • Change in PDI (Psoriasis Disability Index questionnaire) scores [ Time Frame: up to 12 weeks ]
    PDI scale ranges from 0 to 90 with higher scores indicating impaired quality of life.
  • Change in PDI scores as % of the maximum score 90 [ Time Frame: up to 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2017)
  • Drug-related incidence and severity of adverse events [ Time Frame: week 8 ]
    Percentage of patients with incidence and adverse events related to treatment
  • Percentage of patients with drug-related changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Urinalysis laboratory assessments
  • Percentage of patients with abnormal changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Biochemistry laboratory assessments
  • Percentage of patients with drug-related changes in clinical laboratory results from baseline [ Time Frame: week 8 ]
    Hematology and coagulation laboratory assessments
  • 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
  • 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
  • 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
  • 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
  • Percentage of patients with drug-related changes in liver functions from baseline [ Time Frame: week 8 ]
    Laboratory assessments of liver functions
  • Percentage of patients with drug-related changes in renal functions from baseline [ Time Frame: week 8 ]
    Laboratory assessments of renal functions
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Double
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: TC cream
    A well-characterized botanical drug for topical treatment of psoriasis vulgaris
  • Drug: Vehicle
    Vehicle
Study Arms  ICMJE
  • Active Comparator: TC cream (10%)
    Intervention: Drug: TC cream
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
88
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372811
Other Study ID Numbers  ICMJE 105883-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Psoriasis Research Institute of Guangzhou
Study Sponsor  ICMJE Psoriasis Research Institute of Guangzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Psoriasis Research Institute of Guangzhou
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP