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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 14, 2018

Interventions

  • Drug: TC cream
    • A well-characterized botanical drug for topical treatment of psoriasis vulgaris
  • Drug: Vehicle
    • Vehicle

Arms, Groups and Cohorts

  • Active Comparator: TC cream (10%)
  • Placebo Comparator: Vehicle

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Psoriasis Research Institute of Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edward Heilman, MD, Principal Investigator, Department of Dermatology, State University of New York
    • Peter J. Jenkin, MD, Principal Investigator, Dermatology Associates
    • Jiang Yang, Ph.D., Study Director, Psoriasis Research Institute of Guangzhou
    • Liping Yang, MD, Study Chair, Psoriasis Research Institute of Guangzhou

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