Phase 2
N=88
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-IIb Trial)
Psoriasis Vulgaris · Topical Administration
Bottom Line
View on ClinicalTrials.gov: NCT03372811 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Investigator's Static Global Assessment Scale (ISGA) Scores — 1.46; 2.02; 2.57; 2.60 Score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Total coumarin (TC) cream (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Psoriasis Research Institute of Guangzhou
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator's Static Global Assessment Scale (ISGA) Scores |
1.46; 2.02; 2.57; 2.60 | — |
| SECONDARY Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores |
9; 1 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Scores |
6.95; 8.84; 3.49; 6.26 | — |
| SECONDARY Psoriasis Disability Index Questionnaire (PDI) Scores |
9.11; 10.16; 4.98; 7.42 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03372811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.