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

Psoriasis Research Institute of Guangzhou2 sites in 1 country88 target enrollmentJune 11, 2015

ConditionsPsoriasis Vulgaris

InterventionsVehicle Total coumarin (TC) cream

DrugsVehicle

Overview

Phase: Phase 2
Intervention: Vehicle
Conditions: Psoriasis Vulgaris
Sponsor: Psoriasis Research Institute of Guangzhou
Enrollment: 88
Locations: 2
Primary Endpoint: Investigator's Static Global Assessment Scale (ISGA) Scores
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

June 11, 2015

End Date

June 30, 2018

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Psoriasis Research Institute of Guangzhou

Responsible Party

Sponsor

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).

Arms & Interventions

Vehicle

BID for 8 weeks

Intervention: Vehicle

Total coumarin (TC) cream (10%)

BID for 8 weeks

Intervention: Total coumarin (TC) cream

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Percentage of Participants With 75% Improvement in Psoriasis Area and Severity Index (PASI) Scores(Baseline and 8 weeks after treatment)
Dermatology Life Quality Index (DLQI) Scores(Baseline and 8 weeks)
Psoriasis Disability Index Questionnaire (PDI) Scores(Baseline and 8 weeks)