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A Double-blind, Randomized, Placebo-controlled, Parallel-controlled, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC Cream) in Treating Patients With Psoriasis Vulgaris

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to learn if a botanical Total Coumarin topical cream (TC Cream) works to treat psoriasis in adults. It will also learn about the safety of the topical TC Cream. The main questions it aims to answer are: * Does TC Cream improve the psoriasis disease symptoms? * What medical problems do participants have when applying TC Cream? * Does TC Cream improve the quality of life of psoriasis patients? Researchers will compare TC Cream to a placebo cream (a look-alike cream that contains no active drug) to see if TC Cream works to treat psoriasis. Participants will: * Topically apply the TC Cream or a placebo cream twice daily every day to affected skin for 8 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and their diseased skin conditions during the application of the topical cream

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age of 18-70 years old. Both men and women, and members of all races and ethnic groups

• Consistent with the 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

Locations
United States
New York
Department of Dermatology, SUNY Downstate Health Sciences University
RECRUITING
New York
Contact Information
Primary
Jiang Yang, MSc, PhD
terence0731@gmail.com
+1-(608)-772-1251
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 300
Treatments
Active_comparator: Total coumarin (TC) cream (10%)
Twice a day (BID) for 8 weeks
Placebo_comparator: Vehicle cream
Twice a day (BID) for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Psoriasis Research Institute of Guangzhou

This content was sourced from clinicaltrials.gov

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