Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372811
• Other study ID #: 105883-1
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2019
• Source: Psoriasis Research Institute of Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 30, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• TC cream
A well-characterized botanical drug for topical treatment of psoriasis vulgaris
• Vehicle
Vehicle

Locations

Country	Name	City	State
United States	Department of Dermatology, State University of New York, Downstate Medical Center	New York	New York
United States	Dermatology Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Psoriasis Research Institute of Guangzhou

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug-related incidence and severity of adverse events	Percentage of patients with incidence and adverse events related to treatment	week 8
Other	Percentage of patients with drug-related changes in clinical laboratory results from baseline	Urinalysis laboratory assessments	week 8
Other	Percentage of patients with abnormal changes in clinical laboratory results from baseline	Biochemistry laboratory assessments	week 8
Other	Percentage of patients with drug-related changes in clinical laboratory results from baseline	Hematology and coagulation laboratory assessments	week 8
Other	Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Systolic/diastolic blood pressure assessments	week 8 and week 12
Other	Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Pulse rate assessments	week 8 and week 12
Other	Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Respiration rate assessments	week 8 and week 12
Other	Percentage of patients with drug-related changes in physical examination from baseline related to treatment	Body temperature assessments	week 8 and week 12
Other	Percentage of patients with drug-related changes in liver functions from baseline	Laboratory assessments of liver functions	week 8
Other	Percentage of patients with drug-related changes in renal functions from baseline	Laboratory assessments of renal functions	week 8
Other	Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline	Assessments of PR/PQ intervals, QRS duration and QT intervals	week 8
Primary	Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions	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.	up to 12 weeks
Secondary	Change in Psoriasis Area and Severity Index (PASI) scores	PASI is the most extensively used tool to measure severity of psoriasis by combing the severity of lesions (erythema, induration and desquamation) and affected area into one single score. Scale ranges from 0 (no disease) to 72 (maximal disease)	up to 12 weeks
Secondary	Change in 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.	up to 12 weeks
Secondary	Change in 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.	up to 12 weeks