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NCT Number: NCT07426120

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Dermatology, SUNY Downstate Health Sciences University

New York, 11203, United States

Location status: Recruiting

Location contact

Edward Heilman, MD

SUB_INVESTIGATOR

Sharon Glick, MD

PRINCIPAL_INVESTIGATOR

Soodeh Kebir, MD

SUB_INVESTIGATOR

Wei-Li Lee, PhD

CONTACT

[email protected]

+1-(718) 270-1910

Wei-Li Lee, PhD

SUB_INVESTIGATOR

About this study

Participants are put into one of two groups: 1. TC Cream group: receives the cream with the active botanical ingredient; 2. Placebo group: receives a look-alike cream with no active ingredient. Participants will apply the assigned cream twice daily (morning and evening) to psoriasis-affected areas for 8 weeks and will come to the clinic every 2 weeks for checkups and study tests. Doctors will check your skin, measure psoriasis severity, and ask about symptoms and any side effects. The study aims to decide whether TC Cream is a safe, effective topical option for psoriasis and whether it can also help people feel better in daily life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total coumarin (TC) cream

Drug

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.

Other names: TC Cream

Vehicle cream

Drug

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

Other names: Placebo cream, Vehicle

Primary outcomes

  1. Investigator's Global Assessment (IGA) (5-point scale)

    Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)

    0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe

Secondary outcomes

  1. Investigator's Static Global Assessment (ISGA) (6-point scale)

    Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

    A validated, physician-reported outcome measure used to evaluate the overall severity of psoriasis at a single time point

  2. Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage

    Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

    PASI 75 represents a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI) score from baseline, indicating significant clinical improvement.

  3. Itch Numeric Rating Scale (NRS) (11-point scale)

    Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

    NRS is a validated, 11-point patient-reported tool (0 = "no itch", 10 = "worst imaginable itch") used to measure daily peak itch intensity over the past 24 hours, as a quick, self-administered assessment of psoriasis severity.

  4. Dermatology Life Quality Index (DLQI) scores

    Time frame: Baseline and 8 weeks

    The Dermatology Life Quality Index (DLQI) is a validated 10-question questionnaire (0-30 range) that assesses the impact of psoriasis on a patient's life; higher scores indicate greater impairment. Scores are banded to interpret severity: 0-1 (no effect), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), and 21-30 (extremely large effect).

  5. Psoriasis Disability Index questionnaire (PDI) scores

    Time frame: Baseline and 8 weeks

    The Psoriasis Disability Index (PDI) is a 15-question, self-administered questionnaire that assesses the impact of psoriasis on daily life; total scores range from 0 to 45 (higher scores indicate greater impairment). It measures five categories: daily activities, work/school, personal relationships, leisure, and treatment. Each of the 15 questions is typically scored from 0 to 3 (0 = not at all, 1 = a little, 2 = a lot, 3 = very much).

Other outcomes

  1. Percentage of patients with adverse events and severe adverse events related to treatment

    Time frame: During the entire 12 weeks of study

  2. Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline

    Time frame: Baseline and 8 weeks

    White blood cells (number/L), red blood cells (number/L), and urine protein (mg/dL). WBC reflects the body's immune activity-high values commonly suggest infection or inflammation, while low values can occur with viral illness, medication effects, bone-marrow suppression, or severe systemic illness. RBC reflects the blood's oxygen-carrying capacity-low counts point toward anemia, whereas high counts may indicate dehydration/hemoconcentration, chronic low oxygen states, or a marrow disorder. Urine protein indicates protein leakage into the urine, which can be transient (exercise, fever, dehydration, UTI), but if persistent, it suggests kidney injury.

  3. Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline

    Time frame: Baseline and 8 weeks

    White blood cells (WBC, number/L), red blood cells (RBC, number/L), hemoglobin (g/L), platelets ( number/L), complete blood count (CBC, number/L), prothrombin time (sec), partial thromboplastin time (sec). White blood cells indicate immune and inflammatory activity. Red blood cells and hemoglobin reflect oxygen-carrying capacity and are used to detect and characterize anemia or polycythemia/hemoconcentration. Platelets reflect clotting potential and bleeding/thrombosis risk. A complete blood count is a combined panel that reports WBC, RBC/hemoglobin, and platelets to screen for infection, anemia, and hematologic disorders. Prothrombin time assesses the extrinsic coagulation pathway and is used to evaluate bleeding risk and liver function. Partial thromboplastin time assesses the intrinsic pathway and is used to evaluate bleeding disorders and to monitor unfractionated heparin; prolongation suggests factor deficiencies, inhibitors, or anticoagulant effects.

  4. Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment

    Time frame: Baseline and 8 weeks

    systolic pressure (mmHg); diastolic pressure (mmHg). Systolic/diastolic blood pressure (BP) assessment measures the peak arterial pressure during heart contraction (systolic) and the resting pressure between beats (diastolic) and is a core screening and monitoring tool for cardiovascular risk.

  5. Pulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment

    Time frame: Baseline and 8 weeks

    Beats/minute. Pulse rate is the number of heartbeats per minute felt at an artery and provides a quick assessment of cardiovascular status

  6. Respiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment

    Time frame: Baseline and 8 weeks

    Breaths per minute. Respiration rate is the number of breaths per minute and is a sensitive vital sign for respiratory and systemic illness.

  7. Body temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment

    Time frame: Baseline and 8 weeks

    Body temperature (degree Celsius)

  8. Laboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline

    Time frame: Baseline and 8 weeks

    Alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L). These are liver enzymes indicating liver damage.

  9. Laboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline

    Time frame: Baseline and 8 weeks

    Blood urea nitrogen (BUN, mg/dL), creatinine (CR, mg/dL ); BUN dictates the urea concentration in the blood. Creatinine is the by-product of muscle breakdown.

  10. Assessments of PR/PQ intervals, QRS duration, and QT intervals by ECG for patients with drug-related changes from baseline

    Time frame: Baseline and 8 weeks

    ECG intervals are measured in milliseconds (ms) by counting small boxes on the ECG grid and converting to time. PR interval: The time from the start of the P wave to the start of the QRS complex, and it reflects how long the electrical signal takes to travel from the atria through the AV node into the ventricles. PQ interval: Often used interchangeably with PR interval in clinical practice. QRS duration: The width (time length) of the QRS complex, which tells how long ventricular depolarization takes. QT interval: The time from the start of the QRS to the end of the T wave, which is the total time for the ventricles to depolarize and repolarize.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang Yang, MSc, PhD

CONTACT

[email protected]

+1-(608)-772-1251

Sponsors and collaborators

Lead sponsor

Psoriasis Research Institute of Guangzhou

Industry

Registry information

Official study title

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

Acronym: PLANTCOAT-III

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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