Recruiting
Phase 3

TC Cream

Sponsor:

Psoriasis Research Institute of Guangzhou

Code:

NCT07426120

Conditions

Psoriasis Vulgaris

Topical Administration

Phase III

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Total coumarin (TC) cream

Vehicle cream

Study Details

Brief summary:

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

Conditions

Psoriasis Vulgaris

Topical Administration

Phase III

Study ID

NCT07426120

Start date

Feb 1, 2026

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Total coumarin (TC) cream

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

The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients

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 and Locations

Central contacts

Jiang Yang, MSc, PhD

+1-(608)-772-1251terence0731@gmail.com

Locations

Department of Dermatology, SUNY Downstate Health Sciences University

Recruiting

New York, New York, United States, 11203

Contacts

Wei-Li Lee, PhD

+1-(718) 270-1910Wei-Li.Lee@downstate.edu

Principal Investigator:

Sharon Glick, MD

More Information

Sponsor

Psoriasis Research Institute of Guangzhou

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Psoriasis
  • Topical cream
  • Botanical drug
  • FDA IND
  • NMPA approval

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Research Institute of Guangzhou on 2026-02-23.