Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis

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

Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointment; Drug: Calcipotriol Betamethasone ointment and Urea Cream; Drug: Calcipotriol Betamethasone ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects who signed Informed Consent Form；
2. Male or female subjects 18-65 years of age；
3. Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
4. Involved area 1-10% of the body surface area.

Exclusion Criteria:

1. Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
2. Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
3. Known allergy to any component of the test or control drug；
4. Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
5. Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
6. Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
7. Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
8. Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
9. Serious life-threatening condition that allows a life expectancy of less than 2 months；
10. Inability to guarantee taking medications and completing visits as scheduled during the study;
11. Serious infection that is not suitable for external treatment；
12. Any other condition that the investigator deems unsuitable for entering the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcipotriol/Betamethasone and Calcipotriol; Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;	Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointment
Sham Comparator: Calcipotriol/Betamethasone and urea cream; alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period	Drug: Calcipotriol Betamethasone ointment and Urea Cream
Active Comparator: Calcipotriol/Betamethasone; Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period	Drug: Calcipotriol Betamethasone ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psoriasis Area and Severity Index 50 ,75 and 90	week0 and week12

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to recurrence	Any Point In Time after 4 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 26, 2013
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Calcitriol
• Other Study ID Numbers: CUP2012D001