Psoriasis VulgarisPhase 3PLANTCOAT-IIINCT07426120
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)
A Phase 3 study testing Total coumarin (TC) cream in people with Psoriasis Vulgaris and Topical Administration, run by Psoriasis Research Institute of Guangzhou at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris, Topical Administration, Phase III
- What is being tested?
- Total coumarin (TC) cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Dermatology, SUNY Downstate Health Sciences University
New York, New York, 11203
Wei-Li Lee, PhD, +1-(718) 270-1910, Wei-Li.Lee@downstate.edu
Sharon Glick, MD
About this study
Official title: 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
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.
Read more
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
Read the detailed description
Participants are put into one of two groups: 1. TC Cream group: receives the cream with the active botanical ingredient; 2. Placebo group: receives a look-alike cream with no active ingredient. Participants will apply the assigned cream twice daily (morning and evening) to psoriasis-affected areas for 8 weeks and will come to the clinic every 2 weeks for checkups and study tests. Doctors will check your skin, measure psoriasis severity, and ask about symptoms and any side effects. The study aims to decide whether TC Cream is a safe, effective topical option for psoriasis and whether it can also help people feel better in daily life.
- Conditions
- Psoriasis Vulgaris, Topical Administration, Phase III
- Being tested
- Total coumarin (TC) cream, Vehicle cream
- Keywords
- Psoriasis, Topical cream, Botanical drug, FDA IND, NMPA approval
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total coumarin (TC) creamDrug
Also called 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 creamDrug
Also called Placebo cream, Vehicle
The same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients
| Study group | Role | What they receive |
|---|---|---|
| Total coumarin (TC) cream (10%) | Active comparator | Twice a day (BID) for 8 weeks Receives: Drug: Total coumarin (TC) cream |
| Vehicle cream | Placebo comparator | Twice a day (BID) for 8 weeks Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) (5-point scale)
0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe
Measured: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)
Secondary outcomes (5)
Investigator's Static Global Assessment (ISGA) (6-point scale)
A validated, physician-reported outcome measure used to evaluate the overall severity of psoriasis at a single time point
Measured: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage
PASI 75 represents a 75% or greater reduction in the Psoriasis Area and Severity Index (PASI) score from baseline, indicating significant clinical improvement.
Measured: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Itch Numeric Rating Scale (NRS) (11-point scale)
NRS is a validated, 11-point patient-reported tool (0 = "no itch", 10 = "worst imaginable itch") used to measure daily peak itch intensity over the past 24 hours, as a quick, self-administered assessment of psoriasis severity.
Measured: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Dermatology Life Quality Index (DLQI) scores
The Dermatology Life Quality Index (DLQI) is a validated 10-question questionnaire (0-30 range) that assesses the impact of psoriasis on a patient's life; higher scores indicate greater impairment. Scores are banded to interpret severity: 0-1 (no effect), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect), and 21-30 (extremely large effect).
Measured: Baseline and 8 weeks
Psoriasis Disability Index questionnaire (PDI) scores
The Psoriasis Disability Index (PDI) is a 15-question, self-administered questionnaire that assesses the impact of psoriasis on daily life; total scores range from 0 to 45 (higher scores indicate greater impairment). It measures five categories: daily activities, work/school, personal relationships, leisure, and treatment. Each of the 15 questions is typically scored from 0 to 3 (0 = not at all, 1 = a little, 2 = a lot, 3 = very much).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active drug intervention group + Vehicle group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Research Institute of Guangzhou
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liping Yang, MD, Study chair, Psoriasis Research Institute of GuangzhouJiang Yang, MSc, PhD, Study director, Psoriasis Research Institute of GuangzhouSharon A Glick, MD, Principal investigator, Department of Dermatology, SUNY Downstate Health Sciences UniversityJiang Yang, MSc, PhD, Principal investigator, Psoriasis Research Institute of Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426120
- Sponsor's protocol ID
- 105883-4 v.02
- Acronym
- PLANTCOAT-III
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07426120
- Acronym / sponsor ID
- PLANTCOAT-III / 105883-4 v.02
- Conditions
- Psoriasis Vulgaris, Topical Administration, Phase III
- Keywords
- Psoriasis, Topical cream, Botanical drug, FDA IND, NMPA approval
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Psoriasis Research Institute of GuangzhouIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Participants are put into one of two groups: 1. TC Cream group: receives the cream with the active botanical ingredient; 2. Placebo group: receives a look-alike cream with no active ingredient. Participants will apply the assigned cream twice daily (morning and evening) to psoriasis-affected areas for 8 weeks and will come to the clinic every 2 weeks for checkups and study tests. Doctors will check your skin, measure psoriasis severity, and ask about symptoms and any side effects. The study aims to decide whether TC Cream is a safe, effective topical option for psoriasis and whether it can also help people feel better in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active drug intervention group + Vehicle group
| Arm | Type | Receives |
|---|---|---|
| Total coumarin (TC) cream (10%) | Active comparator | Drug: Total coumarin (TC) creamTwice a day (BID) for 8 weeks |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamTwice a day (BID) for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total coumarin (TC) creamAlso: TC CreamA 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. | Drug | Total coumarin (TC) cream (10%) |
| Vehicle creamAlso: Placebo cream, VehicleThe same cream formulation as the active comparator TC Cream except that the vehicle cream does not contain active pharmaceutical ingredients | Drug | Vehicle cream |
Primary outcome
Investigator's Global Assessment (IGA) (5-point scale)
Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after drug withdrawal)
0-4 scale to measure the global severity of psoriasis. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe
5 secondary outcomes
Investigator's Static Global Assessment (ISGA) (6-point scale)
Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Psoriasis Area and Severity Index (PASI) Scores and PASI 75 percentage
Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Itch Numeric Rating Scale (NRS) (11-point scale)
Time frame: Baseline, weeks 2, 4, 6, and 8; week 12 (4 weeks after withdrawal)
Dermatology Life Quality Index (DLQI) scores
Time frame: Baseline and 8 weeks
Psoriasis Disability Index questionnaire (PDI) scores
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of Investigative DermatologyLink provided by the sponsor.
- An abstract on the completed phase IIb U.S. clinical trial of total coumarin cream referenced in Journal of the American Academy of DermatologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liping Yang, MD study chair
Psoriasis Research Institute of Guangzhou
Jiang Yang, MSc, PhD study director
Psoriasis Research Institute of Guangzhou
Sharon A Glick, MD principal investigator
Department of Dermatology, SUNY Downstate Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total coumarin (TC) cream in people with Psoriasis Vulgaris and Topical Administration, run by Psoriasis Research Institute of Guangzhou at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Yang, MSc, PhD (+1-(608)-772-1251, terence0731@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.