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34767

Description

Study ID: 115054 Clinical Study ID: 115054 Study Title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01323673 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Vehicle / Placebo Trade Name: clobetasol propionate Study Indication: Dermatitis, Chronic

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Versions (1)
  1. 1/27/19 1/27/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 27, 2019

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Creative Commons BY-NC 3.0
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    Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673

    English

    Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

    1 forms  
    Visit Date
    Description

    Visit Date

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Or if visit Not Done, enter reason:
    Description

    Or if visit Not Done, enter reason:

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C2826287
    Number of days from Baseline visit (derived)
    Description

    Number of days from Baseline visit (derived)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [1,3]
    C0439228
    UMLS CUI [1,4]
    C0237753
    Efficacy Assessments
    Description

    Efficacy Assessments

    Alias
    UMLS CUI-1
    C1280519
    UMLS CUI-2
    C0220825
    Has the subject used hand moisturizer since the last visit?
    Description

    Has the subject used hand moisturizer since the last visit?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3848663
    UMLS CUI [1,2]
    C0018563
    Investigator Assessment
    Description

    Investigator Assessment

    Investigator Static Global Assessment
    Description

    Investigator Static Global Assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0450973
    ISGA Assessor Name (First Initial, Last Name)
    Description

    ISGA Assessor Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0401804
    UMLS CUI [1,2]
    C0027365
    Subject Assessment
    Description

    Subject Assessment

    Alias
    UMLS CUI-1
    C0681850
    UMLS CUI-2
    C0220825
    Subject Global Assessment
    Description

    Subject Global Assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451514
    Pruritus
    Description

    Pruritus

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0033774
    Stinging
    Description

    Stinging

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0677500
    Burning
    Description

    Burning

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0241057
    Pain
    Description

    Pain

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0030193
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic BP (mmHg)
    Description

    Systolic BP (mmHg)

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic BP (mmHg)
    Description

    Diastolic BP (mmHg)

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse (beats/minute)
    Description

    Pulse (beats/minute)

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Temperature C
    Description

    Temperature C

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Temperature F
    Description

    Temperature F

    Data type

    float

    Measurement units
    • F
    Alias
    UMLS CUI [1]
    C0005903
    F
    End of Study
    Description

    End of Study

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0444930
    Date of Study Completion/ Termination
    Description

    Date of Study Completion/ Termination

    Data type

    date

    Alias
    UMLS CUI [1]
    C4554101
    Reason for Completion / Termination
    Description

    Reason for Completion / Termination

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1283212
    UMLS CUI [1,2]
    C0392360
    If 'Other,' specify
    Description

    If 'Other,' specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Fatal Outcome
    Description

    Fatal Outcome

    Alias
    UMLS CUI-1
    C0206277
    Date of Death
    Description

    Date of Death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Cause of Death
    Description

    Cause of Death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465
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    Similar models

    Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Visit Date
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Or if visit Not Done, enter reason:
    Item
    Or if visit Not Done, enter reason:
    text
    C0545082 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    Number of days from Baseline visit (derived)
    Item
    Number of days from Baseline visit (derived)
    integer
    C0545082 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Item Group
    Efficacy Assessments
    C1280519 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Has the subject used hand moisturizer since the last visit?
    Item
    Has the subject used hand moisturizer since the last visit?
    boolean
    C3848663 (UMLS CUI [1,1])
    C0018563 (UMLS CUI [1,2])
    Item Group
    Investigator Assessment
    Item
    Investigator Static Global Assessment
    integer
    C0450973 (UMLS CUI [1])
    Investigator Static Global Assessment
    Code List
    Investigator Static Global Assessment
    CL Item
    Clear - Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting (0)
    CL Item
    Almost Clear - May be trace faint pink erythema, w/ almost no induration/papulation and no oozing/crusting (1)
    CL Item
    Mild - May be faint erythema w/ mild induration/papulation and no oozing/crusting (2)
    CL Item
    Moderate - May be pink-red erythema w/ moderate induration/papulation and some oozing/crusting (3)
    CL Item
    Severe - May be deep or bright red erythema w/ severe induration/papulation and w/ oozing/crusting (4)
    ISGA Assessor Name
    Item
    ISGA Assessor Name (First Initial, Last Name)
    text
    C0401804 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Item Group
    Subject Assessment
    C0681850 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Item
    Subject Global Assessment
    integer
    C0451514 (UMLS CUI [1])
    Subject Global Assessment
    Code List
    Subject Global Assessment
    CL Item
    My skin is clear (0)
    CL Item
    My dermatitis is minimal, maybe a few light pink areas (1)
    CL Item
    My dermatitis is mild, maybe occasional light pink areas (2)
    CL Item
    My dermatitis is moderate, easily noticeable pink-red areas (3)
    CL Item
    My dermatitis is severe, deep or bright red areas which may be warm when touched (4)
    Item
    Pruritus
    integer
    C0033774 (UMLS CUI [1])
    Pruritus
    Code List
    Pruritus
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Stinging
    integer
    C0677500 (UMLS CUI [1])
    Stinging
    Code List
    Stinging
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Burning
    integer
    C0241057 (UMLS CUI [1])
    Burning
    Code List
    Burning
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item
    Pain
    integer
    C0030193 (UMLS CUI [1])
    Pain
    Code List
    Pain
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic BP (mmHg)
    Item
    Systolic BP (mmHg)
    integer
    C0871470 (UMLS CUI [1])
    Diastolic BP (mmHg)
    Item
    Diastolic BP (mmHg)
    integer
    C0428883 (UMLS CUI [1])
    Pulse (beats/minute)
    Item
    Pulse (beats/minute)
    integer
    C0232117 (UMLS CUI [1])
    Temperature C
    Item
    Temperature C
    float
    C0005903 (UMLS CUI [1])
    Temperature F
    Item
    Temperature F
    float
    C0005903 (UMLS CUI [1])
    Item Group
    End of Study
    C0008972 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Date of Study Completion/ Termination
    Item
    Date of Study Completion/ Termination
    date
    C4554101 (UMLS CUI [1])
    Item
    Reason for Completion / Termination
    integer
    C1283212 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for Completion / Termination
    Code List
    Reason for Completion / Termination
    CL Item
    Completed (1)
    CL Item
    Adverse Event (2)
    CL Item
    Lost to Follow up (3)
    CL Item
    Non- compliance with Study Treatment (4)
    CL Item
    Withdrawal of Consent (5)
    CL Item
    Disease Progression/ Lack of Efficacy (6)
    CL Item
    Death (7)
    CL Item
    Other (8)
    If 'Other,' specify
    Item
    If 'Other,' specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Fatal Outcome
    C0206277 (UMLS CUI-1)
    Date of Death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Cause of Death
    Item
    Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Back to the top of the page 

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