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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPsoriasis Research Institute of Guangzhou

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Total coumarin (TC) cream
  • Vehicle cream

Treatment groups

300 Participants
are divided into 2 treatment groups