Back to resultsEfficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Calcipotriol Betamethasone ointment and Calcipotriol ointment
Calcipotriol Betamethasone ointment
Calcipotriol Betamethasone ointment and Urea Cream
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subjects who signed Informed Consent Form；
- Male or female subjects 18-65 years of age；
- Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
- Involved area 1-10% of the body surface area.
Exclusion Criteria:
- Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
- Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
- Known allergy to any component of the test or control drug；
- Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
- Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
- Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
- Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
- Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
- Serious life-threatening condition that allows a life expectancy of less than 2 months；
- Inability to guarantee taking medications and completing visits as scheduled during the study;
- Serious infection that is not suitable for external treatment；
- Any other condition that the investigator deems unsuitable for entering the study.
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Calcipotriol/Betamethasone and Calcipotriol
Calcipotriol/Betamethasone and urea cream
Calcipotriol/Betamethasone
Arm Description
Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;
alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period
Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index 50 ,75 and 90
Secondary Outcome Measures
Time to recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02191007
Brief Title
Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
Official Title
Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
5. Study Description
Brief Summary
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy
Detailed Description
1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcipotriol/Betamethasone and Calcipotriol
Arm Type
Experimental
Arm Description
Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;
Arm Title
Calcipotriol/Betamethasone and urea cream
Arm Type
Sham Comparator
Arm Description
alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period
Arm Title
Calcipotriol/Betamethasone
Arm Type
Active Comparator
Arm Description
Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period
Intervention Type
Drug
Intervention Name(s)
Calcipotriol Betamethasone ointment and Calcipotriol ointment
Intervention Type
Drug
Intervention Name(s)
Calcipotriol Betamethasone ointment
Intervention Type
Drug
Intervention Name(s)
Calcipotriol Betamethasone ointment and Urea Cream
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index 50 ,75 and 90
Time Frame
week0 and week12
Secondary Outcome Measure Information:
Title
Time to recurrence
Time Frame
Any Point In Time after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who signed Informed Consent Form；
Male or female subjects 18-65 years of age；
Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
Involved area 1-10% of the body surface area.
Exclusion Criteria:
Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
Known allergy to any component of the test or control drug；
Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
Serious life-threatening condition that allows a life expectancy of less than 2 months；
Inability to guarantee taking medications and completing visits as scheduled during the study;
Serious infection that is not suitable for external treatment；
Any other condition that the investigator deems unsuitable for entering the study.
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
We'll reach out to this number within 24 hrs