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

NCT ID: NCT03372811

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2018-06-30

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

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TC cream (10%)

Group Type: ACTIVE_COMPARATOR

TC cream

Intervention Type: DRUG

A well-characterized botanical drug for topical treatment of psoriasis vulgaris

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle

Interventions

TC cream

A well-characterized botanical drug for topical treatment of psoriasis vulgaris

Intervention Type: DRUG

Vehicle

Vehicle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psoriasis Research Institute of Guangzhou

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Heilman, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, State University of New York

Peter J. Jenkin, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Associates

Jiang Yang, Ph.D.

Role: STUDY_DIRECTOR

Psoriasis Research Institute of Guangzhou

Liping Yang, MD

Role: STUDY_CHAIR

Psoriasis Research Institute of Guangzhou

Locations

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

New York, New York, United States

Dermatology Associates

Seattle, Washington, United States

Countries

United States

Other Identifiers

105883-1

Identifier Type: -

Identifier Source: org_study_id