ID

34727

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. 1/25/19 1/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 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

English

Baseline/ Day 1 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

1 forms  
Medical History
Description

Medical History

Alias
UMLS CUI-1
C0262926
If there is no medical history to report, place a check in the box
Description

If there is no medical history to report, place a check in the box

Data type

integer

Disease/ Condition/ Procedure
Description

Use precise medical terminology

Data type

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0348080
UMLS CUI [3]
C0087111
Date of Diagnosis/Procedure
Description

Date of Diagnosis/Procedure

Data type

date

Alias
UMLS CUI [1]
C2316983
UMLS CUI [2]
C2584899
Ongoing at Time of Informed Consent?
Description

Ongoing at Time of Informed Consent?

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [2]
C0021430
Efficacy Assessments- Baseline
Description

Efficacy Assessments- Baseline

Alias
UMLS CUI-1
C1280519
UMLS CUI-2
C0220825
Date of Hand Dermatitis diagnosis
Description

Date of Hand Dermatitis diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0744574
UMLS CUI [1,2]
C2316983
Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?
Description

Has any OTC moisturizer been used on the hands within 30 days of the Baseline visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C3848663
UMLS CUI [1,2]
C0013231
UMLS CUI [1,3]
C0457083
Investigator Assessment
Description

Investigator Assessment

Which hand will be routinely assessed during the study?
Description

Which hand will be routinely assessed during the study?

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0018563
UMLS CUI [1,3]
C0441987
Investigator Static Global Assessment
Description

Investigator Static Global Assessment

Data type

integer

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

ISGA Assessor Name

Data type

text

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

Subject Assessment

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

Subject Global Assessment

Data type

integer

Alias
UMLS CUI [1]
C0451514
Pruritus
Description

Pruritus

Data type

integer

Alias
UMLS CUI [1]
C0033774
Stinging
Description

Stinging

Data type

integer

Alias
UMLS CUI [1]
C0677500
Burning
Description

Burning

Data type

integer

Alias
UMLS CUI [1]
C0241057
Pain
Description

Pain

Data type

integer

Alias
UMLS CUI [1]
C0030193
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic BP (mmHg)
Description

Systolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP (mmHg)
Description

Diastolic BP (mmHg)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse (beats/minute)
Description

Pulse (beats/minute)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature °C
Description

Temperature °C

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature F
Description

Temperature F

Data type

float

Measurement units
  • F
Alias
UMLS CUI [1]
C0005903
F
Urine Pregnancy
Description

Urine Pregnancy

Alias
UMLS CUI-1
C0430056
Urine Pregnancy Test Result
Description

Urine Pregnancy Test Result

Data type

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1274040
If Not Done or Not Applicable, specify reason:
Description

If Not Done or Not Applicable, specify reason:

Data type

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C2826287
If Other, specify:
Description

If Other, specify:

Data type

text

Alias
UMLS CUI [1,1]
C2826287
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
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Similar models

Baseline/ Day 1 - Medical History; Efficacy Assessments- Baseline; Investigator Assessment; Subject Assessment; Vital Signs; Urine Pregnancy

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical History
C0262926 (UMLS CUI-1)
Item
If there is no medical history to report, place a check in the box
integer
If there is no medical history to report, place a check in the box
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])
Date of Diagnosis/Procedure
Item
Date of Diagnosis/Procedure
date
C2316983 (UMLS CUI [1])
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])
Item Group
Efficacy Assessments- Baseline
C1280519 (UMLS CUI-1)
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])
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])
Item Group
Investigator Assessment
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])
Which hand will be routinely assessed during the study?
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])
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)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
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 Group
Urine Pregnancy
C0430056 (UMLS CUI-1)
Item
Urine Pregnancy Test Result
integer
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urine Pregnancy Test Result
Code List
Urine Pregnancy Test Result
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])
If Not Done or Not Applicable, specify reason:
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])
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