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

NCT03372811 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 105883-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Psoriasis Vulgaris; Topical Administration

Keywords

Psoriasis; Topical cream; Botanical drug; FDA IND

Outcome Measures

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.

  Baseline and 8 weeks after treatment

Secondary Outcomes (3)

• Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores

  Baseline and 8 weeks after treatment

• Dermatology Life Quality Index (DLQI) Scores

  Baseline and 8 weeks

• Psoriasis Disability Index Questionnaire (PDI) Scores

  Baseline and 8 weeks

Other Outcomes (11)

• Drug-related Incidence and Severity of Adverse Events

  During the entire study

• Percentage of 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

  Baseline and 8 weeks

Study Arms (2)

Total coumarin (TC) cream (10%)

ACTIVE COMPARATOR

BID for 8 weeks

Drug: Total coumarin (TC) cream

Vehicle

PLACEBO COMPARATOR

BID for 8 weeks

Drug: Vehicle

Interventions

Vehicle DRUG

Vehicle

Vehicle

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.

Also known as: TC Cream

Total coumarin (TC) cream (10%)

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 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 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.

Sponsors & Collaborators

• Psoriasis Research Institute of Guangzhou: lead

Study Sites (2)

Department of Dermatology, State University of New York, Downstate Medical Center

New York, New York, 11203, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• 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

  RESULT

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jiang Yang, Study Director
• Organization: Psoriasis Research Institute of Guangzhou

terence0731@gmail.com

+86-18933940216

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 14, 2017
• Study Start: June 11, 2015
• Primary Completion: March 14, 2018
• Study Completion: June 30, 2018
• Last Updated: March 25, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)