Information:
Fel:
ID
34767
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 (1)
- 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
Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study
Similar models
Day 15/ Early Termination - Visit Date; Efficacy Assessments; Investigator Assessment; Subject Assessment; Vital Signs; End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
C1442488 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
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])
C0018563 (UMLS CUI [1,2])
Item
Investigator Static Global Assessment
integer
C0450973 (UMLS CUI [1])
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])
C0027365 (UMLS CUI [1,2])
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)
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)
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)
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)
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)
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])
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])
C0392360 (UMLS CUI [1,2])
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])
C2348235 (UMLS CUI [1,2])
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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