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

Official title

A Double-blind, Randomized, Placebo-controlled, Parallel-controlled, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC Cream) in Treating Patients With Psoriasis Vulgaris

Overview

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

Detailed description

Participants are put into one of two groups: 1. TC Cream group: receives the cream with the active botanical ingredient; 2. Placebo group: receives a look-alike cream with no active ingredient. Participants will apply the assigned cream twice daily (morning and evening) to psoriasis-affected areas for 8 weeks and will come to the clinic every 2 weeks for checkups and study tests. Doctors will check your skin, measure psoriasis severity, and ask about symptoms and any side effects. The study aims to decide whether TC Cream is a safe, effective topical option for psoriasis and whether it can also help people feel better in daily life.

Interventions

• 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. A previous phase IIb clinical trial has been completed in the U.S.
• Drug Vehicle cream
  The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients

Primary outcome measures

• Investigator's Global Assessment (IGA) (5-point scale) [Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)]

Secondary outcome measures (5)

• Investigator's Static Global Assessment (ISGA) (6-point scale) [Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)]
• Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage [Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)]
• Itch Numeric Rating Scale (NRS) (11-point scale) [Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)]
• Dermatology Life Quality Index (DLQI) scores [Time frame: Baseline and 8 weeks]
• Psoriasis Disability Index questionnaire (PDI) scores [Time frame: Baseline and 8 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Department of Dermatology, SUNY Downstate Health Sciences University — New York

Identifiers

NCT: NCT07426120 · 105883-4 v.02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗