ID

42745

Description

ODM derived from http://clinicaltrials.gov/show/NCT00885937

Link

http://clinicaltrials.gov/show/NCT00885937

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00885937 Healthy

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Skin type I, II, or III according to Fitzpatrick
Description

Skin type I, II, or III according to Fitzpatrick

Data type

boolean

Alias
UMLS CUI 2011AA
C2700185
UMLS CUI 2011AA
C2700186
UMLS CUI 2011AA
C2700187
Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Description

Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
Description

Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.

Data type

boolean

Alias
UMLS CUI 2011AA
C0427350
SNOMED CT 2011_0131
250171008
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0013182
LOINC Version 232
MTHU002637
UMLS CUI 2011AA
C0919578
MedDRA 14.1
10049998
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
CL414967
UMLS CUI 2011AA
C2242995
Cutaneous hypersensitivity
Description

Known skin allergies.

Data type

boolean

Alias
UMLS CUI 2011AA
C0585186
SNOMED CT 2011_0131
21626009
MedDRA 14.1
10011667
Dermatologic diseases that might interfere with the evaluation of test site reaction.
Description

Dermatologic diseases that might interfere with the evaluation of test site reaction.

Data type

boolean

Alias
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0205145
SNOMED CT 2011_0131
10546003
LOINC Version 232
MTHU014632
UMLS CUI 2011AA
C0443286
SNOMED CT 2011_0131
263851003
LOINC Version 232
MTHU014636
Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
Description

Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.

Data type

boolean

Alias
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0852910
MedDRA 14.1
10004950
UMLS CUI 2011AA
C0232407
SNOMED CT 2011_0131
88911008
UMLS CUI 2011AA
C0262595
SNOMED CT 2011_0131
201340008
UMLS CUI 2011AA
C0406208
SNOMED CT 2011_0131
238516007
UMLS CUI 2011AA
C0221258
Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
Description

Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial

Data type

boolean

Alias
UMLS CUI 2011AA
C0010164
SNOMED CT 2011_0131
81024003
LOINC Version 232
MTHU035662
UMLS CUI 2011AA
C0360289
SNOMED CT 2011_0131
350088003
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
Description

Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1710439
SNOMED CT 2011_0131
419487009
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0678889
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0304497
SNOMED CT 2011_0131
373526007
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0011625
SNOMED CT 2011_0131
65628000
Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, beta-receptor blocking drugs, antihistamines) should not be used.
Description

Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, beta-receptor blocking drugs, antihistamines) should not be used.

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C0031001
SNOMED CT 2011_0131
88058003
UMLS CUI 2011AA
C1123023
SNOMED CT 2011_0131
39937001
LOINC Version 232
MTHU001414
UMLS CUI 2011AA
C0042591
SNOMED CT 2011_0131
272735005
UMLS CUI 2011AA
C0042402
SNOMED CT 2011_0131
58944007
UMLS CUI 2011AA
C0042397
SNOMED CT 2011_0131
8571001
UMLS CUI 2011AA
C0001645
SNOMED CT 2011_0131
33252009
LOINC Version 232
MTHU003324
UMLS CUI 2011AA
C0019590
SNOMED CT 2011_0131
372806008
LOINC Version 232
MTHU003328
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Skin type I, II, or III according to Fitzpatrick
Item
Skin type I, II, or III according to Fitzpatrick
boolean
C2700185 (UMLS CUI 2011AA)
C2700186 (UMLS CUI 2011AA)
C2700187 (UMLS CUI 2011AA)
Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Item
Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
boolean
C0681850 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424941 (UMLS CUI 2011AA)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
Item
Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
boolean
C0427350 (UMLS CUI 2011AA)
250171008 (SNOMED CT 2011_0131)
C1744706 (UMLS CUI 2011AA)
C0013182 (UMLS CUI 2011AA)
MTHU002637 (LOINC Version 232)
C0919578 (UMLS CUI 2011AA)
10049998 (MedDRA 14.1)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL414967 (UMLS CUI 2011AA)
C2242995 (UMLS CUI 2011AA)
Known skin allergies.
Item
Cutaneous hypersensitivity
boolean
C0585186 (UMLS CUI 2011AA)
21626009 (SNOMED CT 2011_0131)
10011667 (MedDRA 14.1)
Dermatologic diseases that might interfere with the evaluation of test site reaction.
Item
Dermatologic diseases that might interfere with the evaluation of test site reaction.
boolean
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
C0443286 (UMLS CUI 2011AA)
263851003 (SNOMED CT 2011_0131)
MTHU014636 (LOINC Version 232)
Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
Item
Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
boolean
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0852910 (UMLS CUI 2011AA)
10004950 (MedDRA 14.1)
C0232407 (UMLS CUI 2011AA)
88911008 (SNOMED CT 2011_0131)
C0262595 (UMLS CUI 2011AA)
201340008 (SNOMED CT 2011_0131)
C0406208 (UMLS CUI 2011AA)
238516007 (SNOMED CT 2011_0131)
C0221258 (UMLS CUI 2011AA)
Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
Item
Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
boolean
C0010164 (UMLS CUI 2011AA)
81024003 (SNOMED CT 2011_0131)
MTHU035662 (LOINC Version 232)
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
Item
Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1710439 (UMLS CUI 2011AA)
419487009 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0678889 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0304497 (UMLS CUI 2011AA)
373526007 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0011625 (UMLS CUI 2011AA)
65628000 (SNOMED CT 2011_0131)
Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, beta-receptor blocking drugs, antihistamines) should not be used.
Item
Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, beta-receptor blocking drugs, antihistamines) should not be used.
boolean
C0013227 (UMLS CUI 2011AA)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0031001 (UMLS CUI 2011AA)
88058003 (SNOMED CT 2011_0131)
C1123023 (UMLS CUI 2011AA)
39937001 (SNOMED CT 2011_0131)
MTHU001414 (LOINC Version 232)
C0042591 (UMLS CUI 2011AA)
272735005 (SNOMED CT 2011_0131)
C0042402 (UMLS CUI 2011AA)
58944007 (SNOMED CT 2011_0131)
C0042397 (UMLS CUI 2011AA)
8571001 (SNOMED CT 2011_0131)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
C0019590 (UMLS CUI 2011AA)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial