ID
34829
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)
- 1/30/19 1/30/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 30, 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
Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire
Description
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
no Concomitant Medications including MOISTURIZER to report
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [2,1]
- C3848663
- UMLS CUI [2,2]
- C2347804
Description
Medication
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Administration Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Check if medication continuing at end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0008972
- UMLS CUI [2,2]
- C0444930
Description
Indication Medication (Reason for use)
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Description
Concomitant Procedures
Alias
- UMLS CUI-1
- C1707479
Description
No Concomitant Procedures to report
Data type
text
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C2347804
Description
Procedure
Data type
text
Alias
- UMLS CUI [1]
- C0199171
Description
Start Date of Procedure
Data type
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Description
Stop Date of Procedure
Data type
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Description
Check if Procedure continuing at End of Study
Data type
integer
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0444930
Description
Indication (Reason for procedure)
Data type
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
No Adverse Events to report
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2347804
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Start Date of Adverse Event
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
End Date of Adverse Event
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
Check if Adverse Event continuing at end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826663
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0444930
Description
Adverse Event Severity
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
AE caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0304229
Description
Action taken with Study treatment
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Concomitant or Additional Treatment Given
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706712
- UMLS CUI [1,2]
- C1707479
Description
Was the Adverse Event serious?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
General Comments
Alias
- UMLS CUI-1
- C0947611
Description
Subject's Post-Study Questionnaire
Alias
- UMLS CUI-1
- C0681850
- UMLS CUI-2
- C0034394
- UMLS CUI-3
- C0008972
- UMLS CUI-4
- C0687676
Description
1 - Skin Medicines used in past
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0205156
Description
Gel Preference
Data type
text
Alias
- UMLS CUI [1,1]
- C0017243
- UMLS CUI [1,2]
- C0558295
Description
Lotion Preference
Data type
integer
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0558295
Description
undefined item
Data type
text
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0558295
Description
Cream Preference
Data type
text
Alias
- UMLS CUI [1,1]
- C1378128
- UMLS CUI [1,2]
- C0558295
Description
Ointment Preference
Data type
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0558295
Description
Ointment Preference
Data type
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0558295
Description
Spray Preference
Data type
text
Alias
- UMLS CUI [1,1]
- C4521772
- UMLS CUI [1,2]
- C0558295
Description
2 - Rate Qualities of Foam
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0332306
Description
Foam easy to use
Data type
text
Alias
- UMLS CUI [1,1]
- C0991510
- UMLS CUI [1,2]
- C0457083
- UMLS CUI [1,3]
- C0332219
Description
Able to continue daily activities
Data type
text
Alias
- UMLS CUI [1,1]
- C0001288
- UMLS CUI [1,2]
- C0085732
Description
Leaves my skin feeling soft
Data type
text
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0205358
Description
Able to apply foam to large body surface areas
Data type
text
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0085732
- UMLS CUI [1,3]
- C0991510
Description
Disappears into my skin quickly
Data type
text
Alias
- UMLS CUI [1,1]
- C1701930
- UMLS CUI [1,2]
- C1123023
Description
3 - Rate the Foam
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0220825
Description
Moisturizing
Data type
text
Alias
- UMLS CUI [1]
- C1646056
Description
Lack of residue
Data type
text
Alias
- UMLS CUI [1,1]
- C0332268
- UMLS CUI [1,2]
- C1709915
Description
Does not feel greasy
Data type
text
Alias
- UMLS CUI [1]
- C0234925
Description
Absorbs quickly
Data type
text
Alias
- UMLS CUI [1,1]
- C0000854
- UMLS CUI [1,2]
- C0456962
Description
Easy to apply
Data type
text
Alias
- UMLS CUI [1,1]
- C0185125
- UMLS CUI [1,2]
- C0332219
Description
Fragrance free
Data type
text
Alias
- UMLS CUI [1,1]
- C0031000
- UMLS CUI [1,2]
- C0332296
Description
Spreadability
Data type
text
Alias
- UMLS CUI [1]
- C3846158
Description
Lack of stickiness
Data type
text
Alias
- UMLS CUI [1,1]
- C0392162
- UMLS CUI [1,2]
- C0022902
Description
4 - Compare Foam to Other Types of Skin Medicines
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C1707455
- UMLS CUI-3
- C1123023
- UMLS CUI-4
- C0013227
- UMLS CUI-5
- C0205394
Description
Gel - foam comparison
Data type
text
Alias
- UMLS CUI [1,1]
- C0017243
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Description
Cream - foam comparison
Data type
text
Alias
- UMLS CUI [1,1]
- C1378128
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Description
Ointment - foam comparison
Data type
text
Alias
- UMLS CUI [1,1]
- C0028912
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Description
Lotion - foam comparison
Data type
text
Alias
- UMLS CUI [1,1]
- C0544341
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Description
Spray - foam comparison
Data type
text
Alias
- UMLS CUI [1,1]
- C4521772
- UMLS CUI [1,2]
- C0991510
- UMLS CUI [1,3]
- C1707455
Description
5 - Likely to be compliant using various types of Medicines
Alias
- UMLS CUI-1
- C1321605
- UMLS CUI-2
- C0457083
- UMLS CUI-3
- C0013227
- UMLS CUI-4
- C0443302
Description
Likely w/ a foam
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0991510
Description
Likely w/ a cream
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C1378128
Description
Likely w/ an ointment
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0028912
Description
Likely w/ a gel
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0017243
Description
Likely w/ a lotion
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C0544341
Description
Likely w/ a spray
Data type
text
Alias
- UMLS CUI [1,1]
- C0750501
- UMLS CUI [1,2]
- C4521772
Description
6 - What do you like or not like about the Foam?
Alias
- UMLS CUI-1
- C0991510
- UMLS CUI-2
- C0870814
Similar models
Unscheduled Visit; Concomitant Medications; Concomitant Procedures; Adverse Events; General Comments; Subject's Post-Study Questionnaire
C3854240 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3854240 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C3848663 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
C3146298 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1707479 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0034394 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C0687676 (UMLS CUI-4)
C0034394 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
C0558295 (UMLS CUI [1,2])
C0332306 (UMLS CUI-2)
C0457083 (UMLS CUI [1,2])
C0332219 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,2])
C0205358 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
C0991510 (UMLS CUI [1,3])
C1123023 (UMLS CUI [1,2])
C1707455 (UMLS CUI-2)
C1123023 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0991510 (UMLS CUI [1,2])
C1707455 (UMLS CUI [1,3])
C0457083 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0443302 (UMLS CUI-4)
C0028912 (UMLS CUI [1,2])
C0870814 (UMLS CUI-2)
C0870814 (UMLS CUI [1,2])