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

Conditions

• Phase III
• Psoriasis Vulgaris
• Topical Administration

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Total coumarin (TC) cream — DRUG
  A well-characterized botanical drug for the topical treatment of psoriasis vulgaris. The drug has been approved by the NMPA in China and has obtained an NDA following multiple clinical trials spanning phases I-III in large cohorts. A previous phase IIb clinical trial has been completed in the U.S.
• Vehicle cream — DRUG
  The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients

Study Details

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

Key Dates

Start date

Feb 1, 2026

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Total coumarin (TC) cream (10%)
  Twice a day (BID) for 8 weeks
• Placebo Comparator: Vehicle cream
  Twice a day (BID) for 8 weeks

Primary Outcome Measure

Investigator's Global Assessment (IGA) (5-point scale) [ Time Frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal) ]

Central Contacts

• Jiang Yang, MSc, PhD
  +1-(608)-772-1251
  [email protected]

Locations (1)

Find similar trials in New York, NY

Related Studies

• Psoriatic Immune Response to Tildrakizumab
  PHASE4 · Recruiting · University of California, San Francisco · San Francisco, California
• Correction of Psoriatic T Cell Signatures by Deucravacitinib
  PHASE4 · Recruiting · University of California, San Francisco · San Francisco, California