Total Coumarin Cream for Psoriasis

(PLANTCOAT-III Trial)

Overseen By Jiang Yang, MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Psoriasis Research Institute of Guangzhou

Must not be taking: Corticosteroids, Retinoids, Biologics, others

Disqualifiers: Pregnancy, Cardiovascular diseases, Photosensitivity, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Sharon A Glick, MD

Principal Investigator

Department of Dermatology, SUNY Downstate Health Sciences University

Jiang Yang, MSc, PhD

Principal Investigator

Psoriasis Research Institute of Guangzhou

Liping Yang, MD

Principal Investigator

Psoriasis Research Institute of Guangzhou

Jiang Yang, MSc, PhD

Principal Investigator

Psoriasis Research Institute of Guangzhou

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 70 years old.

I have stable plaque psoriasis with at least two spots that can be checked.

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

Exclusion Criteria

I have used certain psoriasis treatments on my target lesions in the last 4 weeks.

Subjects in pregnancy, preparing for pregnancy, or breastfeeding

History of hyperergic or photosensitivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply TC Cream or placebo cream twice daily for 8 weeks

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Total Coumarin (TC) Cream

How Is the Trial Designed?

Group I: Total coumarin (TC) cream (10%) Active Control 1 Intervention

Twice a day (BID) for 8 weeks

Group II: Vehicle cream Placebo Group 1 Intervention

Twice a day (BID) for 8 weeks

Who Is Running the Clinical Trial?

Psoriasis Research Institute of Guangzhou

Lead Sponsor

Trials

1

Recruited

90+