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
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)
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
Parallel
Total coumarin (TC) cream
DrugA 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.
Vehicle cream
DrugThe same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients
Investigator's Global Assessment (IGA) (5-point scale)
0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe
Investigator's Static Global Assessment (ISGA) (6-point scale)
A validated, physician-reported outcome measure used to evaluate the overall severity of psoriasis at a single time point
Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage
PASI 75 represents a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI) score from baseline, indicating significant clinical improvement.
Itch Numeric Rating Scale (NRS) (11-point scale)
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.
Dermatology Life Quality Index (DLQI) scores
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).
Percentage of patients with adverse events and severe adverse events related to treatment
Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
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.
Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
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.
Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment
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.
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