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Completed

NCT Number: NCT02191007

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcipotriol Betamethasone ointment and Calcipotriol ointment

Drug

Calcipotriol Betamethasone ointment

Drug

Calcipotriol Betamethasone ointment and Urea Cream

Drug

Primary outcomes

  1. Psoriasis Area and Severity Index 50 ,75 and 90

    Time frame: week0 and week12

Secondary outcomes

  1. Time to recurrence

    Time frame: Any Point In Time after 4 weeks

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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