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A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Compound Clobetasol Propionate Ointment
Calcipotriol Betamethasone Ointment
Sponsored by
First Hospital of China Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The informed consent has been signed in;
  2. Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited;
  3. The lesion area does not exceed 10% of the total surface area of the body;
  4. The overall evaluation of the researchers (Physician Global Assessment,PGA) greater than or equal to 2;
  5. The observation of target lesions of minimum diameter greater than or equal to 2cm.

Exclusion Criteria:

  1. Patients who have known or been doubted of being allergic to the composition of the drug;
  2. Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris;
  3. Patients who have illnesses in severe central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system and mental disorders;
  4. Patients with other diseases may affect the assessment of efficacy, such as eczema, etc.;
  5. Liver functions(such as Alanine aminotransferase, Aspartate transaminase) is 2 times greater than(or equal to) the upper limit of normal value, or renal functions (such as creatinine) is 1.5 times greater than(or equal to) the upper limit of normal value;
  6. Patients with hypercalcemia whose serum calcium values exceed the upper limit of the normal value or patients who were suspected of having a disease of hypercalcemia;
  7. Patients who are taking drugs that affect metabolism of calcium. Drugs that increase the serum calcium values: agents containing calcium, active vitamin D3 medication, injection, anabolic agents (ipriflavone preparations); Drugs that decrease the serum calcium values: calcitonin preparation, double phosphate ester compound preparation, sex hormone preparations).
  8. Patients who were randomly divided into groups had received systemic biological treatment (listed or unlisted), such as: ustekinumab treatment accepted by patients after the past 12 weeks, infliximab, adalimumab treatment accepted by patients after the past 8 weeks, infliximab, etanercept treatment accepted by patients after the past 4 weeks accepted and so on;
  9. Patients who have accepted non-abiotic systemic therapy that may have an effect on psoriasis, including but not limited to vitamin A preparations, cortical hormone, vitamin D analogs, immunosuppressant, compound glycyrrhizin, traditional Chinese medicine and so on after the past 4 weeks of random entry or test period.
  10. Patients who have were accepted psoralen ultraviolet A(PUVA) treatment after the past 4 weeks of random entry or test period.
  11. Patients who have accepted ultraviolet therapy or partial treatments of psoriasis drugs after the past 2 weeks of random entry or test period;
  12. Patients who have used concomitant drugs recently in the past 2 weeks after random entry or plan to use concomitant drugs during test period, such as Beta blockers, anti malaria drugs, lithium preparations, etc.;
  13. Patients who have accepted other clinical trials after the the last 4 weeks of random entry;
  14. Patients who work outside for a long time with sun exposure may have an impact on the diagnosis and treatment of the disease.
  15. Women of lactation, pregnancy and childbearing age who refuse to accept effective contraceptive measures.
  16. Patients who have known or been suspected of non-compliance, such as alcoholism, drug dependence or mental illness, etc, and can not be suitable to the clinical trials judged by the investigators.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    test group

    control group

    Arm Description

    Compound Clobetasol Propionate Ointment

    Calcipotriol Betamethasone Ointment

    Outcomes

    Primary Outcome Measures

    The improvement of psoriasis area and severity index scores(PASI scores)
    The improvement of psoriasis area and severity index scores(PASI scores) are a system that assesses the damage of psoriasis severity and treatment response . The system is used to classify and evaluate according to the severity of lesions, areas of skin lesion and body surface area ratio of various body parts.
    The overall evaluation of the researchers (Physician Global Assessment,PGA)
    On every visiting viewpoint , researchers give a mark of the infiltration / hypertrophy (I), erythema (E) and scales (s) according to the level.PGA scores are acquired by the average of above three kinds of scores.
    The Symptom score reduce index (SSRI)
    1)According to the improvement of psoriasis area and severity index scores(PASI scores) before and after treatments, the symptom score reduce index (SSRI) was calculated. 2)The symptom score reduce index (SSRI) = (the PASI scores before treatment - the PASI scores after treatment) / the PASI scores before treatment x 100%
    Efficiency of treatment
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Efficiency of treatment = (The number of healing patients + The number of markedly effective patients + The number of improved patients ) / total number of patients in this group x 100%

    Secondary Outcome Measures

    Healing rate
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Healing rate = The number of healing patients / total number of patients in this group x 100%
    Markedly effective rate
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Markedly effective rate = The number of markedly effective patients / total number of patients in this group x 100%
    Response rate of PASI (PASI 75) after the treatment of 4 weeks
    Response rate of PASI (PASI 75) after the treatment of 4 weeks = The number of patients whose SSRI are more than 75% / total number of patients x 100%
    Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks
    Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks:patients with 1 score of PGA for the last time/ total number of patients in this group x 100%

    Full Information

    First Posted
    March 23, 2016
    Last Updated
    April 13, 2016
    Sponsor
    First Hospital of China Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02733874
    Brief Title
    A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Hospital of China Medical University

    4. Oversight

    5. Study Description

    Brief Summary
    A multi-center, randomized, single blind, positive controlled trials that assess the effectiveness, safety and cost-effectiveness analysis in patients with mild to moderate psoriasis vulgaris and compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment. Objectives of Study: Compare Compound Clobetasol Propionate Ointment to Calcipotriol Betamethasone Ointment in the treatment of mild to moderate psoriasis vulgaris in effectiveness and safety; Compare the cost-effectiveness analysis of two treatment programs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    240 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    test group
    Arm Type
    Experimental
    Arm Description
    Compound Clobetasol Propionate Ointment
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Calcipotriol Betamethasone Ointment
    Intervention Type
    Drug
    Intervention Name(s)
    Compound Clobetasol Propionate Ointment
    Intervention Type
    Drug
    Intervention Name(s)
    Calcipotriol Betamethasone Ointment
    Primary Outcome Measure Information:
    Title
    The improvement of psoriasis area and severity index scores(PASI scores)
    Description
    The improvement of psoriasis area and severity index scores(PASI scores) are a system that assesses the damage of psoriasis severity and treatment response . The system is used to classify and evaluate according to the severity of lesions, areas of skin lesion and body surface area ratio of various body parts.
    Time Frame
    At baseline, 2 weeks and 4 weeks after baseline.
    Title
    The overall evaluation of the researchers (Physician Global Assessment,PGA)
    Description
    On every visiting viewpoint , researchers give a mark of the infiltration / hypertrophy (I), erythema (E) and scales (s) according to the level.PGA scores are acquired by the average of above three kinds of scores.
    Time Frame
    At baseline, 2 weeks and 4 weeks after baseline.
    Title
    The Symptom score reduce index (SSRI)
    Description
    1)According to the improvement of psoriasis area and severity index scores(PASI scores) before and after treatments, the symptom score reduce index (SSRI) was calculated. 2)The symptom score reduce index (SSRI) = (the PASI scores before treatment - the PASI scores after treatment) / the PASI scores before treatment x 100%
    Time Frame
    4 weeks after baseline.
    Title
    Efficiency of treatment
    Description
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Efficiency of treatment = (The number of healing patients + The number of markedly effective patients + The number of improved patients ) / total number of patients in this group x 100%
    Time Frame
    4 weeks after baseline.
    Secondary Outcome Measure Information:
    Title
    Healing rate
    Description
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Healing rate = The number of healing patients / total number of patients in this group x 100%
    Time Frame
    4 weeks after treatment
    Title
    Markedly effective rate
    Description
    1)Healing patients : SSRI ≥ 90%, Marked effectiveness patients : 60% < SSRI < 90%, Improvement patients : 20% < SSRI < 60%, ineffectiveness patients :SSRI < 20%. 2)Markedly effective rate = The number of markedly effective patients / total number of patients in this group x 100%
    Time Frame
    4 weeks after treatment
    Title
    Response rate of PASI (PASI 75) after the treatment of 4 weeks
    Description
    Response rate of PASI (PASI 75) after the treatment of 4 weeks = The number of patients whose SSRI are more than 75% / total number of patients x 100%
    Time Frame
    4 weeks after treatment
    Title
    Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks
    Description
    Response rate of PGA ( basic fading rate of PGA) after the treatment of 4 weeks:patients with 1 score of PGA for the last time/ total number of patients in this group x 100%
    Time Frame
    4 weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The informed consent has been signed in; Patients who were 18~65 years of age, stable psoriasis patients, the gender is not limited; The lesion area does not exceed 10% of the total surface area of the body; The overall evaluation of the researchers (Physician Global Assessment,PGA) greater than or equal to 2; The observation of target lesions of minimum diameter greater than or equal to 2cm. Exclusion Criteria: Patients who have known or been doubted of being allergic to the composition of the drug; Patients who were diagnosed as non-psoriasis vulgaris (such as erythrodermic type, pustular psoriasis, arthritis), and developing psoriasis vulgaris; Patients who have illnesses in severe central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system and mental disorders; Patients with other diseases may affect the assessment of efficacy, such as eczema, etc.; Liver functions(such as Alanine aminotransferase, Aspartate transaminase) is 2 times greater than(or equal to) the upper limit of normal value, or renal functions (such as creatinine) is 1.5 times greater than(or equal to) the upper limit of normal value; Patients with hypercalcemia whose serum calcium values exceed the upper limit of the normal value or patients who were suspected of having a disease of hypercalcemia; Patients who are taking drugs that affect metabolism of calcium. Drugs that increase the serum calcium values: agents containing calcium, active vitamin D3 medication, injection, anabolic agents (ipriflavone preparations); Drugs that decrease the serum calcium values: calcitonin preparation, double phosphate ester compound preparation, sex hormone preparations). Patients who were randomly divided into groups had received systemic biological treatment (listed or unlisted), such as: ustekinumab treatment accepted by patients after the past 12 weeks, infliximab, adalimumab treatment accepted by patients after the past 8 weeks, infliximab, etanercept treatment accepted by patients after the past 4 weeks accepted and so on; Patients who have accepted non-abiotic systemic therapy that may have an effect on psoriasis, including but not limited to vitamin A preparations, cortical hormone, vitamin D analogs, immunosuppressant, compound glycyrrhizin, traditional Chinese medicine and so on after the past 4 weeks of random entry or test period. Patients who have were accepted psoralen ultraviolet A(PUVA) treatment after the past 4 weeks of random entry or test period. Patients who have accepted ultraviolet therapy or partial treatments of psoriasis drugs after the past 2 weeks of random entry or test period; Patients who have used concomitant drugs recently in the past 2 weeks after random entry or plan to use concomitant drugs during test period, such as Beta blockers, anti malaria drugs, lithium preparations, etc.; Patients who have accepted other clinical trials after the the last 4 weeks of random entry; Patients who work outside for a long time with sun exposure may have an impact on the diagnosis and treatment of the disease. Women of lactation, pregnancy and childbearing age who refuse to accept effective contraceptive measures. Patients who have known or been suspected of non-compliance, such as alcoholism, drug dependence or mental illness, etc, and can not be suitable to the clinical trials judged by the investigators.

    12. IPD Sharing Statement

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    A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.

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