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

Mots-clés

Versions (1)
  1. 24/01/2019 24/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

24 janvier 2019

DOI

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Licence

Creative Commons BY-NC 3.0
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Ethanol-Free Clobetasol Propionate Foam vs Vehicle Foam in Chronic Hand Dermatitis NCT01323673

Anglais

Baseline/ Day 1 - Visit Date; Demography; Inclusion, Exclusion Criteria

1 Formulaires  
Visit Date
Description

Visit Date

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Or if visit Not Done, enter reason:
Description

Or if visit Not Done, enter reason:

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C2826287
Number of days from Baseline visit (derived)
Description

Number of days from Baseline visit (derived)

Type de données

integer

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0439228
UMLS CUI [1,4]
C0750480
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Informed Consent
Description

Date of Informed Consent

Type de données

date

Alias
UMLS CUI [1]
C2985782
Dtae of Birth
Description

Dtae of Birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Type de données

text

Alias
UMLS CUI [1]
C0015031
Primary Race
Description

Primary Race

Type de données

integer

Alias
UMLS CUI [1]
C0034510
If other Primary Race, specify
Description

If other Primary Race, specify

Type de données

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Age (at consent)
Description

Age (at consent)

Type de données

integer

Unités de mesure
  • years
Alias
UMLS CUI [1]
C0001779
years
Inclusion/ Exclusion
Description

Inclusion/ Exclusion

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Has the subject met al Inclusion and Exclusion eligibility requirements for this study?
Description

Refer to protocol for the full text of Inclusion / Exclusion criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
UMLS CUI [2]
C0013893
Inlcusion criteria
Description

Inlcusion criteria

Alias
UMLS CUI-1
C1512693
Capable of understanding and willing to provide signed, dated written voluntary informed consent before any protocol procedures are performed.
Description

Written voluntary informed consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0600109
Male or female at least 12 years old at time of consent and at time of first dose.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Able to complete the study and to comply with study instructions.
Description

Able to complete the study and to comply with study instructions.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0205197
Moderate to severe hand dermatitis as defined by an ISGA score of 3 or 4 at Baseline.
Description

Moderate to severe hand dermatitis

Type de données

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
Chronic hand dermatitis diagnosis must be at least 6 months prior to study participation.
Description

Chronic hand dermatitis diagnosis must be at least 6 months prior to study participation.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0744574
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0332152
Sexually active females of childbearing potential must agree to use a medically acceptable method of contraception.
Description

Sexually active females of childbearing potential must agree to use a medically acceptable method of contraception.

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Female who is pregnant, trying to become pregnant, or breast feeding.
Description

Female who is pregnant, trying to become pregnant, or breast feeding.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Received any investigational product w/in 30 days prior to Baseline or scheduled to receive another investigational product during the study period.
Description

Received any investigational product

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0304229
Currently diagnosed with allergic contact dermatitis.
Description

Currently diagnosed with allergic contact dermatitis.

Type de données

boolean

Alias
UMLS CUI [1]
C0162820
ISGA score of 0, 1 or 2 regarding hand dermatitis.
Description

ISGA score of 0, 1 or 2 regarding hand dermatitis.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0744574
UMLS CUI [1,2]
C0449820
Participated in a previous study of the same study product.
Description

Participated in a previous study of the same study product.

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
Current use of any medication which, in opinion of investigator, may affect evaluation of study product or place the subject at undue risk.
Description

Medication affecting evaluation of study product or placing at undue risk

Type de données

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
Currently suffering from disease or condition, which in PI's opinion may affect evaluation of study product or place subject at undue risk.
Description

Disease affecting evaluation of study product or placing at undue risk

Type de données

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
Had any major illness within 30 days before the Baseline visit.
Description

Had any major illness within 30 days before the Baseline visit.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0332152
Considered immunocompromised.
Description

Considered immunocompromised.

Type de données

boolean

Alias
UMLS CUI [1]
C0021051
Current drug or alcohol abuse (drug screening not required).
Description

Current drug or alcohol abuse (drug screening not required).

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521116
Known history or suspected intolerance to any component of the investigational formulations.
Description

Known history or suspected intolerance to any component of the investigational formulations.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Considered unable or unlikely to attend the necessary visits.
Description

Considered unable or unlikely to attend the necessary visits.

Type de données

boolean

Alias
UMLS CUI [1,1]
C2827364
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0008952
Employees of a CRO or Stiefel involved in the study, or an immediate family member of an employee involved in the study.
Description

Employees of a CRO or Stiefel involved in the study, or an immediate family member of an employee involved in the study.

Type de données

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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Similar models

Baseline/ Day 1 - Visit Date; Demography; Inclusion, Exclusion Criteria

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Visit Date
C1320303 (UMLS CUI-1)
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])
Number of days from Baseline visit (derived)
Item
Number of days from Baseline visit (derived)
integer
C1442488 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (UMLS CUI [1])
Dtae of Birth
Item
Dtae of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Primary Race
integer
C0034510 (UMLS CUI [1])
Ethnicity
Code List
Primary Race
CL Item
American or Alaska (1)
CL Item
Native Asian (2)
CL Item
Black (3)
CL Item
Native Hawaiian or Other Pacific Islander (4)
CL Item
White (5)
CL Item
Other (6)
If other Primary Race, specify
Item
If other Primary Race, specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Age (at consent)
Item
Age (at consent)
integer
C0001779 (UMLS CUI [1])
Item Group
Inclusion/ Exclusion
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Has the subject met al Inclusion and Exclusion eligibility requirements for this study?
Item
Has the subject met al Inclusion and Exclusion eligibility requirements for this study?
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0013893 (UMLS CUI [2])
Item Group
Inlcusion criteria
C1512693 (UMLS CUI-1)
Written voluntary informed consent
Item
Capable of understanding and willing to provide signed, dated written voluntary informed consent before any protocol procedures are performed.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Age
Item
Male or female at least 12 years old at time of consent and at time of first dose.
boolean
C0001779 (UMLS CUI [1])
Able to complete the study and to comply with study instructions.
Item
Able to complete the study and to comply with study instructions.
boolean
C0085732 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Moderate to severe hand dermatitis
Item
Moderate to severe hand dermatitis as defined by an ISGA score of 3 or 4 at Baseline.
boolean
C0744574 (UMLS CUI [1,1])
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])
Chronic hand dermatitis diagnosis must be at least 6 months prior to study participation.
Item
Chronic hand dermatitis diagnosis must be at least 6 months prior to study participation.
boolean
C0744574 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Sexually active females of childbearing potential must agree to use a medically acceptable method of contraception.
Item
Sexually active females of childbearing potential must agree to use a medically acceptable method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Female who is pregnant, trying to become pregnant, or breast feeding.
Item
Female who is pregnant, trying to become pregnant, or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Received any investigational product
Item
Received any investigational product w/in 30 days prior to Baseline or scheduled to receive another investigational product during the study period.
boolean
C2348568 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Currently diagnosed with allergic contact dermatitis.
Item
Currently diagnosed with allergic contact dermatitis.
boolean
C0162820 (UMLS CUI [1])
ISGA score of 0, 1 or 2 regarding hand dermatitis.
Item
ISGA score of 0, 1 or 2 regarding hand dermatitis.
boolean
C0744574 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Participated in a previous study of the same study product.
Item
Participated in a previous study of the same study product.
boolean
C2348568 (UMLS CUI [1])
Medication affecting evaluation of study product or placing at undue risk
Item
Current use of any medication which, in opinion of investigator, may affect evaluation of study product or place the subject at undue risk.
boolean
C0013227 (UMLS CUI [1,1])
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])
Disease affecting evaluation of study product or placing at undue risk
Item
Currently suffering from disease or condition, which in PI's opinion may affect evaluation of study product or place subject at undue risk.
boolean
C0012634 (UMLS CUI [1,1])
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])
Had any major illness within 30 days before the Baseline visit.
Item
Had any major illness within 30 days before the Baseline visit.
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Considered immunocompromised.
Item
Considered immunocompromised.
boolean
C0021051 (UMLS CUI [1])
Current drug or alcohol abuse (drug screening not required).
Item
Current drug or alcohol abuse (drug screening not required).
boolean
C0038586 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Known history or suspected intolerance to any component of the investigational formulations.
Item
Known history or suspected intolerance to any component of the investigational formulations.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Considered unable or unlikely to attend the necessary visits.
Item
Considered unable or unlikely to attend the necessary visits.
boolean
C2827364 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Employees of a CRO or Stiefel involved in the study, or an immediate family member of an employee involved in the study.
Item
Employees of a CRO or Stiefel involved in the study, or an immediate family member of an employee involved in the study.
boolean
C0599987 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0035173 (UMLS CUI [2,1])
C0086282 (UMLS CUI [2,2])
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