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Trial record 17 of 272 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT02191007
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
xjpfW, Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Calcipotriol Betamethasone ointment and Calcipotriol ointment Drug: Calcipotriol Betamethasone ointment Drug: Calcipotriol Betamethasone ointment and Urea Cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


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



Primary Outcome Measures :
  1. Psoriasis Area and Severity Index 50 ,75 and 90 [ Time Frame: week0 and week12 ]

Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: Any Point In Time after 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191007


Locations
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China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710000
Sponsors and Collaborators
Xijing Hospital

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Responsible Party: xjpfW, Wang Gang, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02191007     History of Changes
Other Study ID Numbers: CUP2012D001
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents