Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:45 AM
Study NCT ID:
NCT07426120
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind, no information known before unblinding and study completion'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active drug intervention group + Vehicle group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients with adverse events and severe adverse events related to treatment', 'timeFrame': 'During the entire 12 weeks of study'}, {'measure': 'Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline', 'timeFrame': 'Baseline and 8 weeks', 'description': "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."}, {'measure': 'Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Pulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Beats/minute. Pulse rate is the number of heartbeats per minute felt at an artery and provides a quick assessment of cardiovascular status'}, {'measure': 'Respiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Breaths per minute. Respiration rate is the number of breaths per minute and is a sensitive vital sign for respiratory and systemic illness.'}, {'measure': 'Body temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Body temperature (degree Celsius)'}, {'measure': 'Laboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L). These are liver enzymes indicating liver damage.'}, {'measure': 'Laboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Assessments of PR/PQ intervals, QRS duration, and QT intervals by ECG for patients with drug-related changes from baseline', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': "Investigator's Global Assessment (IGA) (5-point scale)", 'timeFrame': 'Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)', 'description': '0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe'}], 'secondaryOutcomes': [{'measure': "Investigator's Static Global Assessment (ISGA) (6-point scale)", 'timeFrame': 'Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)', 'description': 'A validated, physician-reported outcome measure used to evaluate the overall severity of psoriasis at a single time point'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage', 'timeFrame': 'Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)', 'description': 'PASI 75 represents a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI) score from baseline, indicating significant clinical improvement.'}, {'measure': 'Itch Numeric Rating Scale (NRS) (11-point scale)', 'timeFrame': 'Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)', 'description': '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.'}, {'measure': 'Dermatology Life Quality Index (DLQI) scores', 'timeFrame': 'Baseline and 8 weeks', 'description': "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)."}, {'measure': 'Psoriasis Disability Index questionnaire (PDI) scores', 'timeFrame': 'Baseline and 8 weeks', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Topical cream', 'Botanical drug', 'FDA IND', 'NMPA approval'], 'conditions': ['Psoriasis Vulgaris', 'Topical Administration', 'Phase III']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jid.2023.03.623', 'label': 'An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of Investigative Dermatology'}, {'url': 'https://doi.org/10.1016/j.jaad.2024.07.1281', 'label': 'An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of the American Academy of Dermatology'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Does TC Cream improve the psoriasis disease symptoms?\n* What medical problems do participants have when applying TC Cream?\n* 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.\n\nParticipants will:\n\n* Topically apply the TC Cream or a placebo cream twice daily every day to affected skin for 8 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of their symptoms and their diseased skin conditions during the application of the topical cream', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18-70 years old. Both men and women, and members of all races and ethnic groups\n* Consistent with the diagnostic criteria of stable phase psoriasis vulgaris, and have at least two target lesions suitable for evaluation\n* 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.\n* ISGA score ≥ 2 (at least mild severity)\n* BSA (stable stage group): 1%≤ to ≤20%\n* Signed a written informed consent document\n* No additional exposure to the sun\n\nExclusion Criteria:\n\n* Subjects in pregnancy, preparing for pregnancy, or breastfeeding\n* History of hyperergic or photosensitivity\n* History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the hepatic, kidney, and hematopoietic system, or patients with psychiatric disorders\n* History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa\n* Within 4 weeks prior to randomization, patients have taken treatment with the following approved or investigational psoriasis therapies on the target lesions:\n\n * Topical treatments\n * PUVA, UVB, or Grenz ray therapy.\n * Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressants).\n * Any types of other investigational therapies for psoriasis\n* 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).\n* 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.\n* History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.'}, 'identificationModule': {'nctId': 'NCT07426120', 'acronym': 'PLANTCOAT-III', 'briefTitle': 'Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Psoriasis Research Institute of Guangzhou'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '105883-4 v.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total coumarin (TC) cream (10%)', 'description': 'Twice a day (BID) for 8 weeks', 'interventionNames': ['Drug: Total coumarin (TC) cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle cream', 'description': 'Twice a day (BID) for 8 weeks', 'interventionNames': ['Drug: Vehicle cream']}], 'interventions': [{'name': 'Total coumarin (TC) cream', 'type': 'DRUG', 'otherNames': ['TC Cream'], 'description': '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.', 'armGroupLabels': ['Total coumarin (TC) cream (10%)']}, {'name': 'Vehicle cream', 'type': 'DRUG', 'otherNames': ['Placebo cream', 'Vehicle'], 'description': 'The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients', 'armGroupLabels': ['Vehicle cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wei-Li Lee, PhD', 'role': 'CONTACT', 'email': 'Wei-Li.Lee@downstate.edu', 'phone': '+1-(718) 270-1910'}, {'name': 'Sharon Glick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Edward Heilman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Soodeh Kebir, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wei-Li Lee, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Dermatology, SUNY Downstate Health Sciences University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jiang Yang, MSc, PhD', 'role': 'CONTACT', 'email': 'terence0731@gmail.com', 'phone': '+1-(608)-772-1251'}], 'overallOfficials': [{'name': 'Liping Yang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Psoriasis Research Institute of Guangzhou'}, {'name': 'Jiang Yang, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Psoriasis Research Institute of Guangzhou'}, {'name': 'Sharon A Glick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, SUNY Downstate Health Sciences University'}, {'name': 'Jiang Yang, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psoriasis Research Institute of Guangzhou'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psoriasis Research Institute of Guangzhou', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}