Phase III, Psoriasis Vulgaris, Topical Administration
Conditions
Keywords
Psoriasis, Topical cream, Botanical drug, FDA IND, NMPA approval
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
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
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.
DRUGVehicle cream
The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients
Sponsors
Psoriasis Research Institute of Guangzhou
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
Intervention model description
Active drug intervention group + Vehicle group
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) (5-point scale) | Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal) | 0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Static Global Assessment (ISGA) (6-point scale) | Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal) | A validated, physician-reported outcome measure used to evaluate the overall severity of psoriasis at a single time point |
| Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage | Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal) | PASI 75 represents a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI) score from baseline, indicating significant clinical improvement. |
| Itch Numeric Rating Scale (NRS) (11-point scale) | Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal) | NRS is a validated, 11-point patient-reported tool (0 = "no itch", 10 = "worst imaginable itch") used to measure daily peak itch intensity over the past 24 hours, as a quick, self-administered assessment of psoriasis severity. |
| Dermatology Life Quality Index (DLQI) scores | Baseline and 8 weeks | The Dermatology Life Quality Index (DLQI) is a validated 10-question questionnaire (0-30 range) that assesses the impact of psoriasis on a patient's life; higher scores indicate greater impairment. Scores are banded to interpret severity: 0-1 (no effect), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), and 21-30 (extremely large effect). |
| Psoriasis Disability Index questionnaire (PDI) scores | Baseline and 8 weeks | The Psoriasis Disability Index (PDI) is a 15-question, self-administered questionnaire that assesses the impact of psoriasis on daily life; total scores range from 0 to 45 (higher scores indicate greater impairment). It measures five categories: daily activities, work/school, personal relationships, leisure, and treatment. Each of the 15 questions is typically scored from 0 to 3 (0 = not at all, 1 = a little, 2 = a lot, 3 = very much). |
Countries
United States
Contacts
CONTACTJiang Yang, MSc, PhD
STUDY_CHAIRLiping Yang, MD
Psoriasis Research Institute of Guangzhou
STUDY_DIRECTORJiang Yang, MSc, PhD
Psoriasis Research Institute of Guangzhou
PRINCIPAL_INVESTIGATORSharon A Glick, MD
Department of Dermatology, SUNY Downstate Health Sciences University
PRINCIPAL_INVESTIGATORJiang Yang, MSc, PhD
Psoriasis Research Institute of Guangzhou
Outcome results
None listed