ID

34760

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2019-01-27 2019-01-27 -
  2. 2019-01-27 2019-01-27 -
  3. 2019-01-27 2019-01-27 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 januari 2019

DOI

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Licens

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

Engelsk

Day 3 - Visit Date; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

1 Formulär  
Visit Date
Beskrivning

Visit Date

Alias
UMLS CUI-1
C1320303
Date of visit
Beskrivning

Date of visit

Datatyp

date

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

Or if visit Not Done, enter reason:

Datatyp

text

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

Number of days from Baseline visit (derived)

Datatyp

integer

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

Efficacy Assessments

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

Has the subject used hand moisturizer since the last visit?

Datatyp

boolean

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

Investigator Assessment

Investigator Static Global Assessment
Beskrivning

Investigator Static Global Assessment

Datatyp

integer

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

ISGA Assessor Name

Datatyp

text

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

Subject Assessment

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

Subject Global Assessment

Datatyp

integer

Alias
UMLS CUI [1]
C0451514
Pruritus
Beskrivning

Pruritus

Datatyp

integer

Alias
UMLS CUI [1]
C0033774
Stinging
Beskrivning

Stinging

Datatyp

integer

Alias
UMLS CUI [1]
C0677500
Burning
Beskrivning

Burning

Datatyp

integer

Alias
UMLS CUI [1]
C0241057
Pain
Beskrivning

Pain

Datatyp

integer

Alias
UMLS CUI [1]
C0030193
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Similar models

Day 3 - Visit Date; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
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