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

Completed · Phase 2

Conditions studied: Psoriasis Vulgaris, Topical Administration

In brief

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

Key facts

Study ID

NCT03372811

Run by

Psoriasis Research Institute of Guangzhou

People needed

88

Starts

2015-06-11

Expected to finish

2018-06-30

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Department of Dermatology, State University of New York, Downstate Medical Center — New York, New York, United States
• Dermatology Associates — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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