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34727
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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Versies (1)
- 25-01-19 25-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 januari 2019
DOI
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Licentie
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 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy
Similar models
Baseline/ Day 1 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item
If there is no medical history to report, place a check in the box
integer
Code List
If there is no medical history to report, place a check in the box
CL Item
No medical history to report (1)
Disease/ Condition/ Procedure
Item
Disease/ Condition/ Procedure
text
C0012634 (UMLS CUI [1])
C0348080 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0348080 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
Date of Diagnosis/Procedure
Item
Date of Diagnosis/Procedure
date
C2316983 (UMLS CUI [1])
C2584899 (UMLS CUI [2])
C2584899 (UMLS CUI [2])
Ongoing at Time of Informed Consent?
Item
Ongoing at Time of Informed Consent?
boolean
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0549178 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
Efficacy Assessments- Baseline
C1280519 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Date of Hand Dermatitis diagnosis
Item
Date of Hand Dermatitis diagnosis
date
C0744574 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
Item
Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
boolean
C3848663 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,3])
C0013231 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,3])
Item
Which hand will be routinely assessed during the study?
text
C0220825 (UMLS CUI [1,1])
C0018563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C0018563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Code List
Which hand will be routinely assessed during the study?
CL Item
Left (L)
CL Item
Right (R)
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])
Item
Urine Pregnancy Test Result
integer
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not Done/ Not Applicable (3)
Item
If Not Done or Not Applicable, specify reason:
integer
C0430056 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
Code List
If Not Done or Not Applicable, specify reason:
CL Item
Surgically Sterile (not tubal ligation) (1)
CL Item
Post Menopausal (2)
CL Item
Pre Menarche (3)
CL Item
Other (4)
If Other, specify:
Item
If Other, specify:
text
C2826287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])