Actively Recruiting
Efficacy and Safety of a Botanical Total Coumarin Cream in Treating Psoriasis Vulgaris Patients A Double-blind, Randomized, Placebo-controlled Phase III Clinical Trial
Led by Psoriasis Research Institute of Guangzhou · Updated on 2026-02-23
300
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a botanical Total Coumarin topical cream (TC Cream) to see if it helps treat psoriasis vulgaris in adults and to assess its safety. The study compares TC Cream to a placebo cream without active ingredients. The main questions focus on whether TC Cream improves psoriasis symptoms, what medical issues may arise during use, and if it enhances quality of life for those affected. Participants will be randomly assigned to one of two groups: one applying TC Cream and the other applying a placebo cream. Both groups will apply their assigned cream twice daily for 8 weeks. They will visit the clinic every 2 weeks for checkups and tests. The TC Cream is a botanical drug approved in China and studied in previous trials. The placebo cream looks the same but contains no active drug. During the study, participants will have their skin examined and psoriasis severity measured using several scales, including the Investigator's Global Assessment and Psoriasis Area and Severity Index. They will also track symptoms and side effects in a diary. Quality of life will be assessed with questionnaires. Follow-up assessments occur 4 weeks after treatment ends. The involvement lasts for 12 weeks including a 4-week post-treatment observation period.
CONDITIONS
Brief Title
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18-70 years old, any gender and race
- Diagnosed with stable phase psoriasis vulgaris
- Have at least two target lesions suitable for evaluation
- Women of childbearing age must use approved birth control methods during the 8-week study
- Psoriasis severity with ISGA score of 2 or higher
- Body surface area (BSA) involvement between 1% and 20%
- Signed informed consent
- No additional exposure to the sun during the study
You will not qualify if you...
- Currently pregnant, planning pregnancy, or breastfeeding
- History of allergic or photosensitive reactions
- History of serious cardiovascular, cerebrovascular, liver, kidney, blood, or psychiatric diseases
- History of photosensitive diseases like porphyria or Xeroderma pigmentosa
- Use of certain psoriasis treatments within 4 weeks before the study (topical treatments, UV therapies, systemic non-biological treatments, investigational therapies)
- Use of systemic retinoids or biological therapies within 3 months before the study
- Planned changes to medications that affect psoriasis during the study
- Allergic reactions to compounds similar to Coumarins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants apply the assigned cream twice daily to psoriasis-affected areas for 8 weeks and attend clinic visits every 2 weeks for checkups and study tests including skin assessments and symptom evaluations.
Every 2 weeks during treatment (5 visits in total)
Duration - 4 weeks after treatment
Participants attend a final visit 4 weeks after treatment ends to assess the lasting effects of the cream.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Dermatology, SUNY Downstate Health Sciences University
New York, New York, United States, 11203
Actively Recruiting
Research Team
J
Jiang Yang, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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