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])
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])
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Primary Race
integer
C0034510 (UMLS CUI [1])
CL Item
American or Alaska (1)
CL Item
Native Hawaiian or Other Pacific Islander (4)
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])
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])
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])
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])