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

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial (PLANTCOAT-IIb) to Evaluate the Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris

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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Topical Administration
• Intervention / Treatment: Drug: Vehicle; Drug: Total coumarin (TC) cream

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total coumarin (TC) cream (10%); BID for 8 weeks	Drug: Total 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.; Other Names: TC Cream
Placebo Comparator: Vehicle; BID for 8 weeks	Drug: Vehicle; Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Psoriasis Research Institute of Guangzhou
• Investigators: Principal Investigator: Edward Heilman, MD, Department of Dermatology, State University of New York; Principal Investigator: Peter J. Jenkin, MD, Dermatology Associates; Study Director: Jiang Yang, Ph.D., Psoriasis Research Institute of Guangzhou; Study Chair: Liping Yang, MD, Psoriasis Research Institute of Guangzhou

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): June 11, 2015
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Topical cream; Botanical drug; FDA IND
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: 105883-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No