Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)

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

Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III) (NCT07426120) is a Phase 3 interventional studying Psoriasis Vulgaris and Topical Administration, sponsored by Psoriasis Research Institute of Guangzhou. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About 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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Psoriasis Vulgaris, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document - No additional exposure to the sun Who Should NOT Join This Trial: - Subjects in pregnancy, preparing for pregnancy, or breastfeeding - History of hyperergic or photosensitivity - History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the 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 randomization, patients have taken treatment with the 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 immunosuppressants). - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * Subjects in pregnancy, preparing for pregnancy, or breastfeeding * History of hyperergic or photosensitivity * History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the 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 randomization, patients have taken treatment with the 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 immunosuppressants). * 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.

Treatments Being Tested

DRUG

Total coumarin (TC) cream

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 following multiple clinical trials spanning phases I-III in large cohorts. A previous phase IIb clinical trial has been completed in the U.S.

DRUG

Vehicle cream

The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Dermatology, SUNY Downstate Health Sciences University

New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07426120), the sponsor (Psoriasis Research Institute of Guangzhou), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07426120 clinical trial studying?

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: … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07426120?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07426120?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07426120. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07426120. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.