Department of Dermatology, SUNY Downstate Health Sciences University
New York, 11203, United States
Location status: Recruiting
NCT Number: NCT07426120
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
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 3
New York, 11203, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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.
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.
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).
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).
Time frame: During the entire 12 weeks of study
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.
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.
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.
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
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.
Time frame: Baseline and 8 weeks
Body temperature (degree Celsius)
Time frame: Baseline and 8 weeks
Alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L). These are liver enzymes indicating liver damage.
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.
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.
Interested in participating?
Request InfoPsoriasis Research Institute of Guangzhou
Industry
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
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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