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

NCT02191007 | Completed

• 1 other identifier: CUP2012D001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index 50 ,75 and 90

  week0 and week12

Secondary Outcomes (1)

• Time to recurrence

  Any Point In Time after 4 weeks

Study Arms (3)

Calcipotriol/Betamethasone and Calcipotriol

EXPERIMENTAL

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

Calcipotriol/Betamethasone and urea cream

SHAM COMPARATOR

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

Calcipotriol/Betamethasone

ACTIVE COMPARATOR

Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period

Drug: Calcipotriol Betamethasone ointment

Interventions

Calcipotriol Betamethasone ointment and Calcipotriol ointment DRUG

Calcipotriol/Betamethasone and Calcipotriol

Calcipotriol Betamethasone ointment DRUG

Calcipotriol/Betamethasone

Calcipotriol Betamethasone ointment and Urea Cream DRUG

Calcipotriol/Betamethasone and urea cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wang Gang

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: July 15, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

CN (1)