ID

34767

Beschrijving

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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  1. 27-01-19 27-01-19 -
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GlaxoSmithKline

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27 januari 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

Engels

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

1 Formulieren  
Visit Date
Beschrijving

Visit Date

Alias
UMLS CUI-1
C1320303
Date of visit
Beschrijving

Date of visit

Datatype

date

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

Or if visit Not Done, enter reason:

Datatype

text

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

Number of days from Baseline visit (derived)

Datatype

integer

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

Efficacy Assessments

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

Has the subject used hand moisturizer since the last visit?

Datatype

boolean

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

Investigator Assessment

Investigator Static Global Assessment
Beschrijving

Investigator Static Global Assessment

Datatype

integer

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

ISGA Assessor Name

Datatype

text

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

Subject Assessment

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

Subject Global Assessment

Datatype

integer

Alias
UMLS CUI [1]
C0451514
Pruritus
Beschrijving

Pruritus

Datatype

integer

Alias
UMLS CUI [1]
C0033774
Stinging
Beschrijving

Stinging

Datatype

integer

Alias
UMLS CUI [1]
C0677500
Burning
Beschrijving

Burning

Datatype

integer

Alias
UMLS CUI [1]
C0241057
Pain
Beschrijving

Pain

Datatype

integer

Alias
UMLS CUI [1]
C0030193
Vital Signs
Beschrijving

Vital Signs

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

Systolic BP (mmHg)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP (mmHg)
Beschrijving

Diastolic BP (mmHg)

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse (beats/minute)
Beschrijving

Pulse (beats/minute)

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature C
Beschrijving

Temperature C

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature F
Beschrijving

Temperature F

Datatype

float

Maateenheden
  • F
Alias
UMLS CUI [1]
C0005903
F
End of Study
Beschrijving

End of Study

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

Date of Study Completion/ Termination

Datatype

date

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

Reason for Completion / Termination

Datatype

integer

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

If 'Other,' specify

Datatype

text

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

Fatal Outcome

Alias
UMLS CUI-1
C0206277
Date of Death
Beschrijving

Date of Death

Datatype

date

Alias
UMLS CUI [1]
C1148348
Cause of Death
Beschrijving

Cause of Death

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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