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

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointment; Drug: Calcipotriol Betamethasone ointment and Urea Cream; Drug: Calcipotriol Betamethasone ointment

• Registration Number: NCT02191007
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-26
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Study First Posted: 2014-07-15
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcipotriol/Betamethasone and Calcipotriol	Calcipotriol Betamethasone ointment and Calcipotriol ointment	Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;
Calcipotriol/Betamethasone and urea cream	Calcipotriol Betamethasone ointment and Urea Cream	alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period
Calcipotriol/Betamethasone	Calcipotriol Betamethasone ointment	Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index 50 ,75 and 90	week0 and week12

Secondary Outcome Measures

Name	Time	Method
Time to recurrence	Any Point In Time after 4 weeks

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China