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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191007
• Other study ID #: CUP2012D001
• Status: Completed
• Phase: N/A
• First received: December 26, 2013
• Last updated: July 11, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Calcipotriol Betamethasone ointment and Calcipotriol ointment

• Calcipotriol Betamethasone ointment

• Calcipotriol Betamethasone ointment and Urea Cream

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index 50 ,75 and 90		week0 and week12	Yes
Secondary	Time to recurrence		Any Point In Time after 4 weeks	Yes