300 Participants NeededMy employer runs this trial

Total Coumarin Cream for Psoriasis

(PLANTCOAT-III Trial)

JY
Overseen ByJiang Yang, MSc, PhD
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new botanical cream, called Total Coumarin (TC) Cream, can improve psoriasis, a skin condition that causes red, itchy patches. Researchers aim to determine if the cream reduces symptoms and enhances life quality for those with psoriasis, while also monitoring for any side effects. Participants will apply either the TC Cream or a placebo cream to their skin twice daily for 8 weeks. Individuals with stable psoriasis and noticeable skin patches might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. If you've used specific psoriasis treatments on target lesions in the last 4 weeks or systemic treatments in the last 3 months, you might not be eligible. Also, you shouldn't start or change medications that could affect psoriasis during the study.

Is there any evidence suggesting that Total Coumarin Cream is likely to be safe for humans?

Research has shown that Total Coumarin (TC) Cream has undergone safety testing for psoriasis treatment. A previous study found that most patients tolerated TC Cream well, with few experiencing serious side effects. The cream has been safely used in trials and is approved for use in China, indicating it has passed some safety checks. While some people might experience mild side effects like skin irritation, these are uncommon. The current trial aims to confirm these findings and ensure the cream's safety for a broader population.12345

Why do researchers think this study treatment might be promising for psoriasis?

Total Coumarin (TC) Cream is unique because it uses coumarin, a natural compound with potential anti-inflammatory properties, as its active ingredient to treat psoriasis. Unlike most standard treatments, which often include corticosteroids or vitamin D analogs, TC Cream offers a novel mechanism by possibly modulating skin inflammation differently. Researchers are excited about this treatment because it could provide an alternative option with fewer side effects and a more natural approach compared to conventional therapies. The twice-daily application also makes it a straightforward addition to a patient's skincare routine.

What evidence suggests that TC Cream might be an effective treatment for psoriasis?

Research shows that Total Coumarin (TC) Cream effectively treats psoriasis, a skin condition that causes red, itchy patches. Previous studies have demonstrated that TC Cream can significantly improve psoriasis symptoms, making it a promising treatment option. In this trial, participants will receive either the TC Cream or a vehicle cream as a placebo comparator. China has approved the cream due to its effectiveness and minimal side effects. It excels at reducing inflammation, which is crucial for managing psoriasis. Overall, the evidence supports TC Cream as a promising choice for people with psoriasis.13467

Who Is on the Research Team?

SA

Sharon A Glick, MD

Principal Investigator

Department of Dermatology, SUNY Downstate Health Sciences University

JY

Jiang Yang, MSc, PhD

Principal Investigator

Psoriasis Research Institute of Guangzhou

LY

Liping Yang, MD

Principal Investigator

Psoriasis Research Institute of Guangzhou

JY

Jiang Yang, MSc, PhD

Principal Investigator

Psoriasis Research Institute of Guangzhou

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with stable plaque psoriasis and at least two areas of affected skin. Participants must not be pregnant or breastfeeding, should use birth control if needed, and cannot have recently used certain psoriasis treatments or have severe health issues like serious heart, liver, kidney problems, or allergies to coumarins.

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
See 4 more

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
See 5 more

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

Trial Overview

The study compares a botanical Total Coumarin (TC) cream to a placebo cream in treating plaque psoriasis. Participants apply either the TC Cream or placebo twice daily on their skin for 8 weeks while attending regular clinic visits and tracking symptoms.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Total coumarin (TC) cream (10%)Active Control1 Intervention
Group II: Vehicle creamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Psoriasis Research Institute of Guangzhou

Lead Sponsor

Trials
1
Recruited
90+

Citations

Efficacy and Safety of a Botanical Total Coumarin (TC) ...

A well-characterized botanical drug for the topical treatment of psoriasis vulgaris. The drug has been approved by the NMPA in China and has obtained an NDA ...

Efficacy and safety of curcumin in psoriasis: preclinical ... - PMC

CUR as an intervention significantly reduced the expression of inflammatory factors such as IL-6 (std.MD: 4.07%; 95% CI: −6.31 to −1.83; p = 0.0004) and IL-8.

Efficacy and Safety of a Botanical Total Coumarin (TC) Cream ...

... IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris.

Protocol for Phase IIb Clinical Trials of Total Coumarin Cream

It has been proven through phase II and phase III clinical trials conducted in China to have remarkable efficacy and minimal side effects, not only for patients ...

Total Coumarin Cream for Psoriasis (PLANTCOAT-III 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.

Efficacy and Safety of a Botanical Total Coumarin (TC) Cream ...

The goal of this clinical trial is to learn if a botanical Total Coumarin topical cream (TC Cream) works to treat psoriasis in adults.

Efficacy and Safety of a Botanical Total... | Clinical Trial

... 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 ...