Total Coumarin botanical cream for psoriasis vulgaris

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

This trial will try a botanical Total Coumarin cream applied twice daily for 8 weeks to see if it helps adults with mild to moderate psoriasis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Psoriasis Research Institute of Guangzhou (industry)
• Drugs / interventions: efalizumab, infliximab, methotrexate
• Locations: 1 site (New York, New York)
• Trial ID: NCT07426120 on ClinicalTrials.gov

What this trial studies

Adults with stable plaque psoriasis are assigned to receive either the active Total Coumarin (TC) topical cream or a matching placebo cream and will apply it to affected skin twice daily for 8 weeks. Participants come to the clinic every two weeks for skin exams, safety checks, and study tests, and they keep a daily symptom diary. Main outcomes include changes in psoriasis severity, reported symptoms, safety events, and quality of life measures compared between the TC and placebo groups. The goal is to determine if TC cream is a safe and effective topical option for people with psoriasis.

Who should consider this trial

Good fit: Adults aged 18–70 with stable plaque psoriasis affecting 1–20% body surface area and an ISGA score of 2 or higher who can apply topical medication twice daily and attend clinic visits are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have photosensitivity conditions, severe systemic illness, or unstable/extensive psoriasis are unlikely to benefit or be eligible for this topical treatment.

Why it matters

Potential benefit: If effective, the TC cream could reduce psoriasis symptoms and improve quality of life as a new topical botanical treatment option.

How similar studies have performed: Some early-stage and small studies of botanical or coumarin-containing topicals have suggested possible benefit, but large phase III evidence for this specific approach is limited.

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.

Where this trial is running

New York, New York

• Department of Dermatology, SUNY Downstate Health Sciences University — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Sharon A Glick, MD — Department of Dermatology, SUNY Downstate Health Sciences University
• Study coordinator: Jiang Yang, MSc, PhD

Conditions: Psoriasis Vulgaris, Topical Administration, Phase III, Psoriasis, Topical cream, Botanical drug, FDA IND, NMPA approval