RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether plant-based Total Coumarin (TC) cream is safe and helps adults ages 18–70 with stable psoriasis, a disease that causes patches on the skin. It compares TC cream with a look-alike cream with no active drug, including how they affect symptoms and quality of life. Participants use the cream twice a day for 8 weeks, visit the clinic every 2 weeks, and keep a symptom diary.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–70 years old. People of all sexes, races, and ethnic groups may join.
  • Have stable psoriasis vulgaris, the common type of psoriasis, with at least two skin patches that can be checked.
  • Have psoriasis rated at least mild by the study's skin scoring tool.
  • Have psoriasis covering 1%–20% of the body.
  • If you are a woman who can become pregnant, use condoms and/or birth control pills during the 8-week study.
  • Sign a written form agreeing to take part.
  • Avoid extra sun exposure.

Who can't join

  • Be pregnant, planning pregnancy, or breastfeeding.
  • Have a history of strong allergic reactions or sensitivity to sunlight.
  • Have complex heart or blood vessel disease, disease of blood vessels in the brain, serious liver, kidney, or blood-forming disease, or a mental health disorder.
  • Have a history of diseases that cause sun sensitivity, such as porphyria, chronic actinic dermatitis, or xeroderma pigmentosa.
  • Have used certain psoriasis treatments within 4 weeks before study group assignment: skin treatments, light or radiation treatments, most medicines that work throughout the body, or experimental treatments.
  • Have used retinoids or biologic medicines that work throughout the body and may affect psoriasis within 3 months before study group assignment.
  • Plan to start or change other medicines that could affect psoriasis during the study, such as beta blockers, malaria drugs, or lithium.
  • Have had an allergic reaction to substances similar to coumarins, the ingredients being tested.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY