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

NCT07426120 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 105883-4 v.02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does TC Cream improve the psoriasis disease symptoms?
• What medical problems do participants have when applying TC Cream?
• 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. Participants will:
• Topically apply the TC Cream or a placebo cream twice daily every day to affected skin for 8 weeks
• Visit the clinic once every 2 weeks for checkups and tests
• Keep a diary of their symptoms and their diseased skin conditions during the application of the topical cream

Conditions

Psoriasis Vulgaris; Topical Administration; Phase III

Keywords

Psoriasis; Topical cream; Botanical drug; FDA IND; NMPA approval

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment (IGA) (5-point scale)

  0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe

  Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)

Secondary Outcomes (5)

• Investigator's Static Global Assessment (ISGA) (6-point scale)

  Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

• Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage

  Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

• Itch Numeric Rating Scale (NRS) (11-point scale)

  Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)

• Dermatology Life Quality Index (DLQI) scores

  Baseline and 8 weeks

• Psoriasis Disability Index questionnaire (PDI) scores

  Baseline and 8 weeks

Other Outcomes (10)

• Percentage of patients with adverse events and severe adverse events related to treatment

  During the entire 12 weeks of study

• Urinalysis laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline

  Baseline and 8 weeks

• Hematology and coagulation laboratory assessments for patients with drug-related changes in clinical laboratory results from baseline

  Baseline and 8 weeks

Study Arms (2)

Total coumarin (TC) cream (10%)

ACTIVE COMPARATOR

Twice a day (BID) for 8 weeks

Drug: Total coumarin (TC) cream

Vehicle cream

PLACEBO COMPARATOR

Twice a day (BID) for 8 weeks

Drug: Vehicle cream

Interventions

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. A previous phase IIb clinical trial has been completed in the U.S.

Also known as: TC Cream

Total coumarin (TC) cream (10%)

Vehicle cream DRUG

The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients

Also known as: Placebo cream, Vehicle

Vehicle cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-70 years old. Both men and women, and members of all races and ethnic groups
• Consistent with the 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

You may not qualify if:

• Subjects in pregnancy, preparing for pregnancy, or breastfeeding
• History of hyperergic or photosensitivity
• History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the 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 randomization, patients have taken treatment with the 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 immunosuppressants).
• 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.

Sponsors & Collaborators

• Psoriasis Research Institute of Guangzhou: lead

Study Sites (1)

Department of Dermatology, SUNY Downstate Health Sciences University

New York, New York, 11203, United States

RECRUITING

Related Links

• An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of Investigative Dermatology
• An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of the American Academy of Dermatology

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Liping Yang, MD

  Psoriasis Research Institute of Guangzhou

  STUDY CHAIR

• Jiang Yang, MSc, PhD

  Psoriasis Research Institute of Guangzhou

  STUDY DIRECTOR

• Sharon A Glick, MD

  Department of Dermatology, SUNY Downstate Health Sciences University

  PRINCIPAL INVESTIGATOR

• Jiang Yang, MSc, PhD

  Psoriasis Research Institute of Guangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Yang, MSc, PhD

CONTACT

+1-(608)-772-1251; terence0731@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, no information known before unblinding and study completion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active drug intervention group + Vehicle group

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)