Clinical trial NCT03372811: Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: Psoriasis Research Institute of Guangzhou
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of TC cream 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.

Primary outcomes:
measure: Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) scores
timeFrame: up to 12 weeks
measure: Change in Dermatology Life Quality Index (DLQI) scores
timeFrame: up to 12 weeks
measure: Change in Psoriasis Disability Index questionnaire (PDI) scores
timeFrame: up to 12 weeks
Other outcomes:
measure: Drug-related incidence and severity of adverse events
timeFrame: week 8
measure: Percentage of patients with drug-related changes in clinical laboratory results from baseline
timeFrame: week 8
measure: Percentage of patients with abnormal changes in clinical laboratory results from baseline
timeFrame: week 8
measure: Percentage of patients with drug-related changes in clinical laboratory results from baseline
timeFrame: week 8
measure: Percentage of patients with drug-related changes in physical examination from baseline related to treatment
timeFrame: week 8 and week 12
measure: Percentage of patients with drug-related changes in physical examination from baseline related to treatment
timeFrame: week 8 and week 12
measure: Percentage of patients with drug-related changes in physical examination from baseline related to treatment
timeFrame: week 8 and week 12
measure: Percentage of patients with drug-related changes in physical examination from baseline related to treatment
timeFrame: week 8 and week 12
measure: Percentage of patients with drug-related changes in liver functions from baseline
timeFrame: week 8
measure: Percentage of patients with drug-related changes in renal functions from baseline
timeFrame: week 8
measure: Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline
timeFrame: week 8
Locations:
city: New York
country: United States
facility: Department of Dermatology, State University of New York, Downstate Medical Center
state: New York
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
Study officials:
affiliation: Department of Dermatology, State University of New York
name: Edward Heilman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Associates
name: Peter J. Jenkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psoriasis Research Institute of Guangzhou
name: Jiang Yang, Ph.D.
role: STUDY_DIRECTOR
affiliation: Psoriasis Research Institute of Guangzhou
name: Liping Yang, MD
role: STUDY_CHAIR
References: