ID
34705
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
Keywords
Versions (1)
- 1/24/19 1/24/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 24, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673
Baseline/ Day 1 - Visit Date; Demography; Inclusion, Exclusion Criteria
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Informed Consent
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Dtae of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Primary Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
If other Primary Race, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Age (at consent)
Data type
integer
Measurement units
- years
Alias
- UMLS CUI [1]
- C0001779
Description
Inclusion/ Exclusion
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Description
Inlcusion criteria
Alias
- UMLS CUI-1
- C1512693
Description
Written voluntary informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [1,3]
- C0600109
Description
Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Able to complete the study and to comply with study instructions.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1321605
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C0205197
Description
Moderate to severe hand dermatitis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0744574
- UMLS CUI [1,2]
- C0205081
- UMLS CUI [1,3]
- C0449820
- UMLS CUI [2,1]
- C0744574
- UMLS CUI [2,2]
- C0205082
- UMLS CUI [2,3]
- C0449820
Description
Chronic hand dermatitis diagnosis must be at least 6 months prior to study participation.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0744574
- UMLS CUI [1,2]
- C0008679
- UMLS CUI [1,3]
- C2603343
- UMLS CUI [1,4]
- C0332152
Description
Sexually active females of childbearing potential must agree to use a medically acceptable method of contraception.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0700589
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Female who is pregnant, trying to become pregnant, or breast feeding.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
Received any investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0304229
Description
Currently diagnosed with allergic contact dermatitis.
Data type
boolean
Alias
- UMLS CUI [1]
- C0162820
Description
ISGA score of 0, 1 or 2 regarding hand dermatitis.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0744574
- UMLS CUI [1,2]
- C0449820
Description
Participated in a previous study of the same study product.
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Medication affecting evaluation of study product or placing at undue risk
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0220825
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0681850
- UMLS CUI [2,3]
- C1444641
Description
Disease affecting evaluation of study product or placing at undue risk
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0220825
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C0681850
- UMLS CUI [2,3]
- C1444641
Description
Had any major illness within 30 days before the Baseline visit.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0221423
- UMLS CUI [1,2]
- C0205164
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C0332152
Description
Considered immunocompromised.
Data type
boolean
Alias
- UMLS CUI [1]
- C0021051
Description
Current drug or alcohol abuse (drug screening not required).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0521116
Description
Known history or suspected intolerance to any component of the investigational formulations.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0304229
Description
Considered unable or unlikely to attend the necessary visits.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2827364
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [1,3]
- C0008952
Description
Employees of a CRO or Stiefel involved in the study, or an immediate family member of an employee involved in the study.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0599987
- UMLS CUI [1,2]
- C2347796
- UMLS CUI [2,1]
- C0035173
- UMLS CUI [2,2]
- C0086282
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Baseline/ Day 1 - Visit Date; Demography; Inclusion, Exclusion Criteria
C2826287 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0680251 (UMLS CUI [1,2])
C0013893 (UMLS CUI [2])
C0085732 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0205081 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0744574 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
C0008679 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0700589 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0304229 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0681850 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0205164 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0521116 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,2])
C0035173 (UMLS CUI [2,1])
C0086282 (UMLS CUI [2,2])