Total Coumarin botanical cream for psoriasis vulgaris

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: terence0731@gmail.com
• Phone: +1-(608)-772-1251

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.