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CompletedNCT03372811PLANTCOAT-IIbUpdated Mar 25, 2026Results posted

Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-IIb Trial)

A Phase 2 interventional study of Total coumarin (TC) cream and Vehicle in Psoriasis Vulgaris and Topical Administration, sponsored by Psoriasis Research Institute of Guangzhou. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Psoriasis Research Institute of Guangzhou · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Psoriasis Vulgaris
  • Topical Administration

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Keywords

  • Psoriasis
  • Topical cream
  • Botanical drug
  • FDA IND
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age of 18-70 years old. Both men and women and members of all races and ethnic groups
  • Consistent with 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)
  • BSA (stable stage group): 1%≤ to ≤20%
  • Signed a written informed consent document
  • No additional exposure to the sun

Exclusion 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:

    • Topical treatments
    • PUVA, UVB or Grenz ray therapy.
    • Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
    • Any types of other investigational therapies for psoriasis
  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Active comparator
    Total coumarin (TC) cream (10%)

    BID for 8 weeks

    Drug: Total coumarin (TC) cream

  • Placebo comparator
    Vehicle

    BID for 8 weeks

    Drug: Vehicle

Interventions

  • DrugTotal coumarin (TC) cream

    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.

    Also known as: TC Cream

  • DrugVehicle

    Vehicle

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks after treatment

Secondary outcomes

  1. 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.

    Time frame: Baseline and 8 weeks after treatment

  2. 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.

    Time frame: Baseline and 8 weeks

  3. 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.

    Time frame: Baseline and 8 weeks

Other outcomes

  1. Drug-related Incidence and Severity of Adverse Events

    Percentage of patients with incidence and adverse events related to treatment

    Time frame: During the entire study

  2. 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

    Time frame: Baseline and 8 weeks

  3. 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

    Time frame: Baseline and 8 weeks

  4. 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

    Time frame: Baseline and 8 weeks

  5. 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

    Time frame: Baseline and 8 weeks

  6. 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

    Time frame: Baseline and 8 weeks

  7. 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

    Time frame: Baseline and 8 weeks

  8. 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

    Time frame: Baseline and 8 weeks

  9. 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

    Time frame: Baseline and 8 weeks

  10. 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

    Time frame: Baseline and 8 weeks

  11. 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

    Time frame: Baseline and 8 weeks

06

Results

Posted Mar 12, 2026

Participant flow

Participant flow — Overall Study
MilestoneTotal Coumarin (TC) Cream GroupVehicle Cream Group
Started4444
Completed4136
Not completed38

Outcome measures

PrimaryInvestigator'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.

Time frame:
Baseline and 8 weeks after treatment
Reported as:
Mean · Score
Investigator's Static Global Assessment Scale (ISGA) Scores
ScoreTotal Coumarin (TC) Cream GroupVehicle Cream Group
ISGA at week 8 after treatment1.46 ± 0.722.02 ± 0.70
ISGA at the baseline before treatment2.57 ± 0.532.60 ± 0.58
SecondaryPercentage 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.

Time frame:
Baseline and 8 weeks after treatment
Reported as:
Count of participants · Participants
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores
ParticipantsTotal Coumarin (TC) Cream GroupVehicle Cream Group
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores91
SecondaryDermatology 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · Score
Dermatology Life Quality Index (DLQI) Scores
ScoreTotal Coumarin (TC) Cream GroupVehicle Cream Group
DLQI at the baseline6.95 ± 6.848.84 ± 7.27
DLQI after 8 weeks of interventions3.49 ± 5.056.26 ± 6.05
SecondaryPsoriasis 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.

Time frame:
Baseline and 8 weeks
Reported as:
Mean · Score
Psoriasis Disability Index Questionnaire (PDI) Scores
ScoreTotal Coumarin (TC) Cream GroupVehicle Cream Group
PDI score at the baseline9.11 ± 10.9610.16 ± 9.31
PDI score after 8 weeks of treatment4.98 ± 7.097.42 ± 8.44
Other pre-specifiedDrug-related Incidence and Severity of Adverse Events

Percentage of patients with incidence and adverse events related to treatment

Time frame:
During the entire study

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Other pre-specifiedPercentage 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

Time frame:
Baseline and 8 weeks

Results for this outcome have not been posted.

Adverse events

Collected over from enrollment until the end of follow-up, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Total Coumarin Cream Group0/44 (0%)0/44 (0%)3/44 (6.8%)
Vehicle0/44 (0%)0/44 (0%)2/44 (4.5%)
Most frequent other events
Most frequent other events
EventTotal Coumarin Cream GroupVehicle
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders2/441/44
Urinary Tract InfectionRenal and urinary disorders1/440/44
ShinglesSkin and subcutaneous tissue disorders0/441/44

Baseline characteristics

Baseline characteristics in each arm

Age, Continuous
Age, Continuous(years)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Mean47.84 ± 15.9753.11 ± 14.5350.48 ± 15.41
Sex: Female, Male
Sex: Female, Male(Participants)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Female101121
Male343367
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
American Indian or Alaska Native000
Asian527
Native Hawaiian or Other Pacific Islander000
Black or African American91221
White242246
More than one race6612
Unknown or Not Reported022
Region of Enrollment
Region of Enrollment(Participants)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
United States444488
Investigator's Static Global Assessment (ISGA)
Investigator's Static Global Assessment (ISGA)(Score)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Mean2.57 ± 0.532.60 ± 0.582.585 ± 0.556
Height (cm)
Height (cm)(cm)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Mean173.19 ± 10.02175.21 ± 8.70174.21 ± 9.38
Body weight (kg)
Body weight (kg)(kg)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Mean86.84 ± 20.4487.77 ± 17.5387.30 ± 18.95
Body mass index (kg/m2)
Body mass index (kg/m2)(kg/m2)Active Comparator: Total Coumarin (TC) CreamPlacebo Comparator: Vehicle CreamTotal
Median28.98 ± 5.4728.43 ± 4.6228.71 ± 5.04

7 further baseline measures are reported on the registry.

07

Study locations

2 sites
  • Department of Dermatology, State University of New York, Downstate Medical Center
    New York, New York 11203, United States
  • Dermatology Associates
    Seattle, Washington 98101, United States
08

References and documents

Publications

  • 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
  • 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

Study documents

  • Protocol and statistical analysis plan · Mar 28, 2011

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03372811
Lead sponsor
Psoriasis Research Institute of Guangzhou
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Jun 11, 2015
Primary completion
Mar 14, 2018
Completion
Jun 30, 2018
Results posted
Mar 12, 2026
Last update
Mar 25, 2026

Study contacts

Edward Heilman, MD
principal investigator · Department of Dermatology, State University of New York
Peter J. Jenkin, MD
principal investigator · Dermatology Associates
Jiang Yang, Ph.D.
study director · Psoriasis Research Institute of Guangzhou
Liping Yang, MD
study chair · Psoriasis Research Institute of Guangzhou

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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