Psoriasis VulgarisPhase 2PLANTCOAT-IIbNCT03372811
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-IIb Trial)
A Phase 2 study testing Total coumarin (TC) cream in people with Psoriasis Vulgaris and Topical Administration, run by Psoriasis Research Institute of Guangzhou at 2 sites in United States.
Trial summary
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris, Topical Administration
- What is being tested?
- Total coumarin (TC) cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jun 2015to 30 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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 breast feeding
- History of hyperergic or photosensitivity
- History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of 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 randomizations, patients have taken treatment with 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 immunosuppressant).
- 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
2 sites in 1 country.
United States2 sites
Department of Dermatology, State University of New York, Downstate Medical Center
New York, New York, 11203
Dermatology Associates
Seattle, Washington, 98101
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial (PLANTCOAT-IIb) to Evaluate the Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris
- Conditions
- Psoriasis Vulgaris, Topical Administration
- Being tested
- Total coumarin (TC) cream, Vehicle
- Keywords
- Psoriasis, Topical cream, Botanical drug, FDA IND
- 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.
VehicleDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Total coumarin (TC) cream (10%) | Active comparator | BID for 8 weeks Receives: Drug: Total coumarin (TC) cream |
| Vehicle | Placebo comparator | BID for 8 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Static Global Assessment Scale (ISGA) Scores
ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
Measured: Baseline and 8 weeks after treatment
Secondary outcomes (3)
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores
PASI is the most widely used tool to measure psoriasis severity, combining the severity of lesions (erythema, induration, and desquamation) and the affected area into a single score. Scale ranges from 0 (no disease) to 72 (maximal disease). A PASI 75% represents a 75% reduction from baseline, indicating a substantial improvement in psoriasis symptoms.
Measured: Baseline and 8 weeks after treatment
Dermatology Life Quality Index (DLQI) Scores
DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life.
Measured: Baseline and 8 weeks
Psoriasis Disability Index Questionnaire (PDI) Scores
PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life.
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 posted14 Dec 2017
- Study start11 Jun 2015
- Primary completion14 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psoriasis Research Institute of Guangzhou
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Heilman, MD, Principal investigator, Department of Dermatology, State University of New YorkPeter J. Jenkin, MD, Principal investigator, Dermatology AssociatesJiang Yang, Ph.D., Study director, Psoriasis Research Institute of GuangzhouLiping Yang, MD, Study chair, Psoriasis Research Institute of Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372811
- Sponsor's protocol ID
- 105883-1
- Acronym
- PLANTCOAT-IIb
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2017
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kabir S, Yang L, Heilman E, Jenkin P, Siegel D, Glick SA, Lee WL. TC Cream is a novel botanical topical product for the treatment of psoriasis. J Am Acad Dermatol. 2024;91(3 Suppl):AB322. doi: 10.1016/j.jaad.2024.07.1281
Yang J, Heilman E, Jenkin P, Lee W, Siegel D, Yang L. TC cream is a novel botanical topical therapy for the treatment of psoriasis. J Invest Dermatol. 2023;143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.623
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial (PLANTCOAT-IIb) to Evaluate the Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT03372811
- Acronym / sponsor ID
- PLANTCOAT-IIb / 105883-1
- Conditions
- Psoriasis Vulgaris, Topical Administration
- Keywords
- Psoriasis, Topical cream, Botanical drug, FDA IND
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Psoriasis Research Institute of GuangzhouIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of a Botanical Total Coumarin Cream (TC) in Treating Patients with Psoriasis Vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total coumarin (TC) cream (10%) | Active comparator | Drug: Total coumarin (TC) creamBID for 8 weeks |
| Vehicle | Placebo comparator | Drug: VehicleBID 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 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 breast feeding
- History of hyperergic or photosensitivity
- History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of 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 randomizations, patients have taken treatment with 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. | Drug | Total coumarin (TC) cream (10%) |
| VehicleVehicle | Drug | Vehicle |
Primary outcome
Investigator's Static Global Assessment Scale (ISGA) Scores
Time frame: Baseline and 8 weeks after treatment
ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
3 secondary outcomes
Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores
Time frame: Baseline and 8 weeks after treatment
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationKabir S, Yang L, Heilman E, Jenkin P, Siegel D, Glick SA, Lee WL. TC Cream is a novel botanical topical product for the treatment of psoriasis. J Am Acad Dermatol. 2024;91(3 Suppl):AB322. doi: 10.1016/j.jaad.2024.07.1281
- Results publicationYang J, Heilman E, Jenkin P, Lee W, Siegel D, Yang L. TC cream is a novel botanical topical therapy for the treatment of psoriasis. J Invest Dermatol. 2023;143(5 Suppl):S105. doi: 10.1016/j.jid.2023.03.623
- 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. This study is not recruiting at the moment.
Edward Heilman, MD principal investigator
Department of Dermatology, State University of New York
Peter J. Jenkin, MD principal investigator
Dermatology Associates
Jiang Yang, Ph.D. study director
Psoriasis Research Institute of Guangzhou
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Total coumarin (TC) cream in people with Psoriasis Vulgaris and Topical Administration, run by Psoriasis Research Institute of Guangzhou at 2 sites 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Static Global Assessment Scale (ISGA) Scores (time frame: Baseline and 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372811, which also lists 2 linked publications.
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 25 Mar 2026.