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Completed

NCT Number: NCT03372811

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 to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris

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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Topical Administration

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TC Cream

Vehicle

Drug

Vehicle

Primary outcomes

  1. Investigator's Static Global Assessment Scale (ISGA) Scores

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Dermatology Life Quality Index (DLQI) Scores

    Time frame: 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.

  3. Psoriasis Disability Index Questionnaire (PDI) Scores

    Time frame: 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.

Other outcomes

  1. Drug-related Incidence and Severity of Adverse Events

    Time frame: During the entire study

    Percentage of patients with incidence and adverse events related to treatment

  2. Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline

    Time frame: Baseline and 8 weeks

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

  3. Percentage of Patients With Abnormal Changes in Clinical Laboratory Results From Baseline

    Time frame: Baseline and 8 weeks

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

  4. Percentage of Patients With Drug-related Changes in Clinical Laboratory Results From Baseline

    Time frame: Baseline and 8 weeks

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

  5. Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment

    Time frame: Baseline and 8 weeks

    Systolic/diastolic blood pressure assessments for patients with drug-related changes in physical examination from baseline related to treatment

  6. Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment

    Time frame: Baseline and 8 weeks

    Pulse rate assessments for patients with drug-related changes in physical examination from baseline related to treatment

  7. Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment

    Time frame: Baseline and 8 weeks

    Respiration rate assessments for patients with drug-related changes in physical examination from baseline related to treatment

  8. Percentage of Patients With Drug-related Changes in Physical Examination From Baseline Related to Treatment

    Time frame: Baseline and 8 weeks

    Body temperature assessments for patients with drug-related changes in physical examination from baseline related to treatment

  9. Percentage of Patients With Drug-related Changes in Liver Functions From Baseline

    Time frame: Baseline and 8 weeks

    Laboratory assessments of liver functions for patients with drug-related changes in clinical laboratory results from baseline

  10. Percentage of Patients With Drug-related Changes in Renal Functions From Baseline

    Time frame: Baseline and 8 weeks

    Laboratory assessments of renal functions for patients with drug-related changes in clinical laboratory results from baseline

  11. Percentage of Patients With Drug-related Changes in Electrocardiography (ECG) From Baseline

    Time frame: Baseline and 8 weeks

    Assessments of PR/PQ intervals, QRS duration and QT intervals for patients with drug-related changes from baseline

Sponsors and collaborators

Lead sponsor

Psoriasis Research Institute of Guangzhou

Industry

Registry information

Official study title

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

Acronym: PLANTCOAT-IIb

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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