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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03372811

Acronym

PLANTCOAT-IIb

Enrollment

Registered

2017-12-14

Start date

2015-06-11

Completion date

2018-06-30

Last updated

2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris, Topical Administration

Keywords

Psoriasis, Topical cream, Botanical drug, FDA IND

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

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.

DRUGVehicle

Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind, no information known before unblinding and study completion

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Investigator's Static Global Assessment Scale (ISGA) Scores	Baseline and 8 weeks after treatment	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores	Baseline and 8 weeks after treatment	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.
Dermatology Life Quality Index (DLQI) Scores	Baseline and 8 weeks	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.
Psoriasis Disability Index Questionnaire (PDI) Scores	Baseline and 8 weeks	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREdward Heilman, MD

Department of Dermatology, State University of New York

PRINCIPAL_INVESTIGATORPeter J. Jenkin, MD

Dermatology Associates

STUDY_DIRECTORJiang Yang, Ph.D.

Psoriasis Research Institute of Guangzhou

STUDY_CHAIRLiping Yang, MD