Trial Outcomes & Findings for Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-IIb Trial) (NCT NCT03372811)
NCT ID: NCT03372811
Last Updated: 2026-03-25
Results Overview
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.
COMPLETED
PHASE2
88 participants
Baseline and 8 weeks after treatment
2026-03-25
Participant Flow
Participant milestones
| Measure |
Total Coumarin (TC) Cream Group
Total coumarin cream, 10%, BID for 8 weeks
|
Vehicle Cream Group
Vehicle cream, BID for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
proportions of female and male participants
Baseline characteristics by cohort
| Measure |
Active Comparator: Total Coumarin (TC) Cream
n=44 Participants
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)
|
Placebo Comparator: Vehicle Cream
n=44 Participants
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)
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.84 years
STANDARD_DEVIATION 15.97 • n=138 Participants
|
53.11 years
STANDARD_DEVIATION 14.53 • n=62 Participants
|
50.48 years
STANDARD_DEVIATION 15.41 • n=123 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=138 Participants • proportions of female and male participants
|
11 Participants
n=62 Participants • proportions of female and male participants
|
21 Participants
n=123 Participants • proportions of female and male participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=138 Participants • proportions of female and male participants
|
33 Participants
n=62 Participants • proportions of female and male participants
|
67 Participants
n=123 Participants • proportions of female and male participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants • Proportions of different races in the population
|
0 Participants
n=62 Participants • Proportions of different races in the population
|
0 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=138 Participants • Proportions of different races in the population
|
2 Participants
n=62 Participants • Proportions of different races in the population
|
7 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants • Proportions of different races in the population
|
0 Participants
n=62 Participants • Proportions of different races in the population
|
0 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=138 Participants • Proportions of different races in the population
|
12 Participants
n=62 Participants • Proportions of different races in the population
|
21 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
White
|
24 Participants
n=138 Participants • Proportions of different races in the population
|
22 Participants
n=62 Participants • Proportions of different races in the population
|
46 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=138 Participants • Proportions of different races in the population
|
6 Participants
n=62 Participants • Proportions of different races in the population
|
12 Participants
n=123 Participants • Proportions of different races in the population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants • Proportions of different races in the population
|
2 Participants
n=62 Participants • Proportions of different races in the population
|
2 Participants
n=123 Participants • Proportions of different races in the population
|
|
Region of Enrollment
United States
|
44 Participants
n=138 Participants • Proportions of subjects enrolled in the study from the United States
|
44 Participants
n=62 Participants • Proportions of subjects enrolled in the study from the United States
|
88 Participants
n=123 Participants • Proportions of subjects enrolled in the study from the United States
|
|
Investigator's Static Global Assessment (ISGA)
|
2.57 Score
STANDARD_DEVIATION 0.53 • n=138 Participants
|
2.60 Score
STANDARD_DEVIATION 0.58 • n=62 Participants
|
2.585 Score
STANDARD_DEVIATION 0.556 • n=123 Participants
|
|
Height (cm)
|
173.19 cm
STANDARD_DEVIATION 10.02 • n=138 Participants
|
175.21 cm
STANDARD_DEVIATION 8.70 • n=62 Participants
|
174.21 cm
STANDARD_DEVIATION 9.38 • n=123 Participants
|
|
Body weight (kg)
|
86.84 kg
STANDARD_DEVIATION 20.44 • n=138 Participants
|
87.77 kg
STANDARD_DEVIATION 17.53 • n=62 Participants
|
87.30 kg
STANDARD_DEVIATION 18.95 • n=123 Participants
|
|
Body mass index (kg/m2)
|
28.98 kg/m2
STANDARD_DEVIATION 5.47 • n=138 Participants
|
28.43 kg/m2
STANDARD_DEVIATION 4.62 • n=62 Participants
|
28.71 kg/m2
STANDARD_DEVIATION 5.04 • n=123 Participants
|
|
Body temperature (℃)
|
36.66 degrees Celsius (℃)
STANDARD_DEVIATION 0.84 • n=138 Participants
|
36.77 degrees Celsius (℃)
STANDARD_DEVIATION 0.41 • n=62 Participants
|
36.71 degrees Celsius (℃)
STANDARD_DEVIATION 0.66 • n=123 Participants
|
|
Pulse Rate (bpm), continuous
|
72.20 bpm
STANDARD_DEVIATION 11.81 • n=138 Participants
|
76.48 bpm
STANDARD_DEVIATION 11.11 • n=62 Participants
|
74.34 bpm
STANDARD_DEVIATION 11.60 • n=123 Participants
|
|
Respiration Rate (bpm), continuous
|
15.18 bpm
STANDARD_DEVIATION 2.05 • n=138 Participants
|
15.82 bpm
STANDARD_DEVIATION 2.14 • n=62 Participants
|
15.50 bpm
STANDARD_DEVIATION 2.11 • n=123 Participants
|
|
Systolic blood pressure (SBP) in mmHg, continuous
|
125.20 mmHg
STANDARD_DEVIATION 14.25 • n=138 Participants
|
128.16 mmHg
STANDARD_DEVIATION 13.85 • n=62 Participants
|
126.68 mmHg
STANDARD_DEVIATION 14.05 • n=123 Participants
|
|
Diastolic blood pressure (DBP) in mmHg, continuous
|
78.27 mmHg
STANDARD_DEVIATION 8.67 • n=138 Participants
|
78.77 mmHg
STANDARD_DEVIATION 8.91 • n=62 Participants
|
78.52 mmHg
STANDARD_DEVIATION 8.74 • n=123 Participants
|
|
Course of disease in month(s), continuous
|
143.52 month
STANDARD_DEVIATION 124.06 • n=138 Participants
|
183.91 month
STANDARD_DEVIATION 169.65 • n=62 Participants
|
163.72 month
STANDARD_DEVIATION 149.15 • n=123 Participants
|
|
Course of this onset in month(s), continuous
|
48.40 Month
STANDARD_DEVIATION 73.50 • n=138 Participants
|
43.40 Month
STANDARD_DEVIATION 86.74 • n=62 Participants
|
45.90 Month
STANDARD_DEVIATION 79.96 • n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks after treatmentISGA 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.
Outcome measures
| Measure |
Total Coumarin (TC) Cream Group
n=44 Participants
Total coumarin cream, 10%, BID for 8 weeks
|
Vehicle Cream Group
n=44 Participants
Vehicle cream, BID for 8 weeks
|
|---|---|---|
|
Investigator's Static Global Assessment Scale (ISGA) Scores
ISGA at week 8 after treatment
|
1.46 Score
Standard Deviation 0.72
|
2.02 Score
Standard Deviation 0.70
|
|
Investigator's Static Global Assessment Scale (ISGA) Scores
ISGA at the baseline before treatment
|
2.57 Score
Standard Deviation 0.53
|
2.60 Score
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks after treatmentPopulation: PASI 75% improvement
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.
Outcome measures
| Measure |
Total Coumarin (TC) Cream Group
n=41 Participants
Total coumarin cream, 10%, BID for 8 weeks
|
Vehicle Cream Group
n=38 Participants
Vehicle cream, BID for 8 weeks
|
|---|---|---|
|
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksDLQI 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.
Outcome measures
| Measure |
Total Coumarin (TC) Cream Group
n=44 Participants
Total coumarin cream, 10%, BID for 8 weeks
|
Vehicle Cream Group
n=44 Participants
Vehicle cream, BID for 8 weeks
|
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Scores
DLQI at the baseline
|
6.95 Score
Standard Deviation 6.84
|
8.84 Score
Standard Deviation 7.27
|
|
Dermatology Life Quality Index (DLQI) Scores
DLQI after 8 weeks of interventions
|
3.49 Score
Standard Deviation 5.05
|
6.26 Score
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPDI 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.
Outcome measures
| Measure |
Total Coumarin (TC) Cream Group
n=42 Participants
Total coumarin cream, 10%, BID for 8 weeks
|
Vehicle Cream Group
n=38 Participants
Vehicle cream, BID for 8 weeks
|
|---|---|---|
|
Psoriasis Disability Index Questionnaire (PDI) Scores
PDI score at the baseline
|
9.11 Score
Standard Deviation 10.96
|
10.16 Score
Standard Deviation 9.31
|
|
Psoriasis Disability Index Questionnaire (PDI) Scores
PDI score after 8 weeks of treatment
|
4.98 Score
Standard Deviation 7.09
|
7.42 Score
Standard Deviation 8.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the entire studyPercentage of patients with incidence and adverse events related to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksUrinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksBiochemistry laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksHematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksSystolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksPulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksRespiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksBody temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksLaboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksLaboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 weeksAssessments of PR/PQ intervals, QRS duration and QT intervals for patients with drug-related changes from baseline
Outcome measures
Outcome data not reported
Adverse Events
Total Coumarin Cream Group
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Total Coumarin Cream Group
n=44 participants at risk
Total coumarin (TC) cream (10%) BID for 8 weeks
|
Vehicle
n=44 participants at risk
Vehicle, BID for 8 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.5%
2/44 • from enrollment until the end of follow-up, up to 12 weeks
|
2.3%
1/44 • from enrollment until the end of follow-up, up to 12 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.3%
1/44 • from enrollment until the end of follow-up, up to 12 weeks
|
0.00%
0/44 • from enrollment until the end of follow-up, up to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/44 • from enrollment until the end of follow-up, up to 12 weeks
|
2.3%
1/44 • from enrollment until the end of follow-up, up to 12 weeks
|
Additional Information
Jiang Yang, Study Director
Psoriasis Research Institute of Guangzhou
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place