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A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total coumarin (TC) cream (10%) | Active Comparator | BID for 8 weeks |
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| Vehicle | Placebo Comparator | BID for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Static Global Assessment Scale (ISGA) Scores | ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome. | Baseline and 8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores | PASI is the most widely used tool to measure psoriasis severity, combining the severity of lesions (erythema, induration, and desquamation) and the affected area into a single score. Scale ranges from 0 (no disease) to 72 (maximal disease). A PASI 75% represents a 75% reduction from baseline, indicating a substantial improvement in psoriasis symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug-related Incidence and Severity of Adverse Events | Percentage of patients with incidence and adverse events related to treatment | During the entire study |
| Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline |
Inclusion Criteria:
Exclusion Criteria:
Subjects in pregnancy, preparing for pregnancy or breast feeding
History of hyperergic or photosensitivity
History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of 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 randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Edward Heilman, MD | Department of Dermatology, State University of New York | Principal Investigator |
| Peter J. Jenkin, MD | Dermatology Associates | Principal Investigator |
| Jiang Yang, Ph.D. | Psoriasis Research Institute of Guangzhou | Study Director |
| Liping Yang, MD | Psoriasis Research Institute of Guangzhou | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, State University of New York, Downstate Medical Center | New York | New York | 11203 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Kabir S, Yang L, Heilman E, Jenkin P, Siegel D, Glick SA, Lee WL. TC Cream is a novel botanical topical product for the treatment of psoriasis. J Am Acad Dermatol. 2024;91(3 Suppl):AB322. doi: 10.1016/j.jaad.2024.07.1281 | ||
| Result | Yang J, Heilman E, Jenkin P, Lee W, Siegel D, Yang L. TC cream is a novel botanical topical therapy for the treatment of psoriasis. J Invest Dermatol. 2023;143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.623 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Coumarin (TC) Cream Group | Total coumarin cream, 10%, BID for 8 weeks |
| FG001 | Vehicle Cream Group | Vehicle cream, BID for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2011 |
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Double-blind, no information known before unblinding and study completion
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| Vehicle | Drug | Vehicle |
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| Baseline and 8 weeks after treatment |
| Dermatology Life Quality Index (DLQI) Scores | DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life. | Baseline and 8 weeks |
| Psoriasis Disability Index Questionnaire (PDI) Scores | PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life. | Baseline and 8 weeks |
Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
| Baseline and 8 weeks |
| Percentage of Patients With Abnormal Changes in Clinical Laboratory Results From Baseline | Biochemistry laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline | Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Pulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Respiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Body temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Liver Functions From Baseline | Laboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Renal Functions From Baseline | Laboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline | Baseline and 8 weeks |
| Percentage of Patients With Drug-related Changes in Electrocardiography (ECG) From Baseline | Assessments of PR/PQ intervals, QRS duration and QT intervals for patients with drug-related changes from baseline | Baseline and 8 weeks |
| Dermatology Associates |
| Seattle |
| Washington |
| 98101 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics in each arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Total Coumarin (TC) Cream | Active Comparator, total coumarin (TC) cream, was applied twice a day (BID) for 8 weeks. Indices measured at the baseline after enrollment before randomization and allocation into groups: Age (yrs), Sex (F/M), BMI, Weight (kg), Height (cm), Race, Body Temperature (℃), Pulse Rate (bpm), Respiration Rate (bpm), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Course of Disease (months), Course of the current onset (months), Clinical Stage (stable Yes/No; First onset or recurrent) |
| BG001 | Placebo Comparator: Vehicle Cream | The placebo comparator, vehicle cream, was applied twice daily (BID) for 8 weeks. Indices measured at the baseline after enrollment before randomization and allocation into groups: Age (yrs), Sex (F/M), BMI, Weight (kg), Height (cm), Race, Body Temperature (℃), Pulse Rate (bpm), Respiration Rate (bpm), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Course of Disease (months), Course of the current onset (months), Clinical Stage (stable Yes/No; First onset or recurrent) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of years, continuous value | Mean | Standard Deviation | years |
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| Sex: Female, Male | Counts of participants in male or female | proportions of female and male participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Counts of participants in different races | Proportions of different races in the population | Count of Participants | Participants |
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| Region of Enrollment | Number of subjects enrolled in the study from the United States | Proportions of subjects enrolled in the study from the United States | Count of Participants | Participants |
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| Investigator's Static Global Assessment (ISGA) | The 6-point Global Investigator's Static Global Assessment (ISGA) scale is a, commonly used in atopic dermatitis trials to grade disease severity from 0 to 5: Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), and Very Severe (5) | Mean | Standard Deviation | Score |
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| Height (cm) | Height of participants in cm, continuous | Mean | Standard Deviation | cm |
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| Body weight (kg) | Body weight of participants in kg (kilogram), continuous | Mean | Standard Deviation | kg |
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| Body mass index (kg/m2) | BMI of participants in kg(kilogram)/m2(square meter), continuous | Median | Standard Deviation | kg/m2 |
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| Body temperature (℃) | Body temperature of participants in degrees Celsius (℃), continuous | Mean | Standard Deviation | degrees Celsius (℃) |
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| Pulse Rate (bpm), continuous | Pulse Rate of participants in bpm (beats per minute), continuous | Mean | Standard Deviation | bpm |
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| Respiration Rate (bpm), continuous | Respiration rate of participants in bpm (breaths per minute), continuous | Mean | Standard Deviation | bpm |
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| Systolic blood pressure (SBP) in mmHg, continuous | Systolic blood pressure (SBP) of participants in mmHg (millimeters of mercury), continuous | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure (DBP) in mmHg, continuous | Diastolic blood pressure (DBP) of participants in mmHg (millimeters of mercury), continuous | Mean | Standard Deviation | mmHg |
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| Course of disease in month(s), continuous | Course of disease in month(s) for participants, continuous | Mean | Standard Deviation | month |
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| Course of this onset in month(s), continuous | Course of this disease onset for participants in month(s), continuous | Mean | Standard Deviation | Month |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator's Static Global Assessment Scale (ISGA) Scores | ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome. | Posted | Mean | Standard Deviation | Score | Baseline and 8 weeks after treatment |
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| Secondary | Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores | PASI is the most widely used tool to measure psoriasis severity, combining the severity of lesions (erythema, induration, and desquamation) and the affected area into a single score. Scale ranges from 0 (no disease) to 72 (maximal disease). A PASI 75% represents a 75% reduction from baseline, indicating a substantial improvement in psoriasis symptoms. | PASI 75% improvement | Posted | Count of Participants | Participants | Baseline and 8 weeks after treatment |
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| Secondary | Dermatology Life Quality Index (DLQI) Scores | DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life. | Posted | Mean | Standard Deviation | Score | Baseline and 8 weeks |
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| Secondary | Psoriasis Disability Index Questionnaire (PDI) Scores | PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life. | Posted | Mean | Standard Deviation | Score | Baseline and 8 weeks |
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| Other Pre-specified | Drug-related Incidence and Severity of Adverse Events | Percentage of patients with incidence and adverse events related to treatment | Not Posted | During the entire study | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline | Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Abnormal Changes in Clinical Laboratory Results From Baseline | Biochemistry laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline | Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Pulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Respiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment | Body temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Liver Functions From Baseline | Laboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Renal Functions From Baseline | Laboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline | Not Posted | Baseline and 8 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Patients With Drug-related Changes in Electrocardiography (ECG) From Baseline | Assessments of PR/PQ intervals, QRS duration and QT intervals for patients with drug-related changes from baseline | Not Posted | Baseline and 8 weeks | Participants |
from enrollment until the end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Coumarin Cream Group | Total coumarin (TC) cream (10%) BID for 8 weeks | 0 | 44 | 0 | 44 | 3 | 44 |
| EG001 | Vehicle | Vehicle, BID for 8 weeks | 0 | 44 | 0 | 44 | 2 | 44 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Two mild and one mild cases reported in the TC Cream and vehicle group, respectively. |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment | A female subject reported moderate UTI |
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| Shingles | Skin and subcutaneous tissue disorders | Systematic Assessment | A female patient reported moderate Shingles that last for 10 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiang Yang, Study Director | Psoriasis Research Institute of Guangzhou | +86-18933940216 | terence0731@gmail.com |
| Jan 11, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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