ID

114

Description

ODM derived from http://clinicaltrials.gov/ct2/show/NCT00148213?term=NCT00148213&rank=1

Link

http://clinicaltrials.gov/ct2/show/NCT00148213?term=NCT00148213&rank=1

Keywords

Versions (2)
  1. 11/24/11 11/24/11 -
  2. 7/9/15 7/9/15 - Martin Dugas
Uploaded on

November 24, 2011

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00216879 Psoriasis

English

Eligibility

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

Inclusion Criteria

18 Years and older
Description

age

Data type

boolean

Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
Description

Scalp psoriasis

Data type

boolean

Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
Description

Psoriasis vulgaris

Data type

boolean

Extent of scalp psoriasis involving more than 10% of the total scalp area
Description

Extension

Data type

boolean

Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity
Description

Disease severity

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
Description

PUVA or Grenz ray Radiation therapy

Data type

boolean

UVB therapy anywhere on the patient within 14 days prior to randomisation
Description

UVB therapy

Data type

boolean

Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
Description

Biologicals

Data type

boolean

Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
Description

Systemic treatment with effect on scalp psoriasis

Data type

boolean

Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
Description

topical treatment for scalp

Data type

boolean

Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
Description

Topical treatment with very potent WHO group IV corticosteroids

Data type

boolean

Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
Description

Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis

Data type

boolean

Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
Description

guttate, pustular, exfoliative or erythrodermic psoriasis

Data type

boolean

Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
Description

viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin on the scalp

Data type

boolean

Known or suspected severe renal insufficiency or severe hepatic disorders
Description

renal insufficiency or severe hepatic disorders

Data type

boolean

Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
Description

clinically significant hypercalcaemia

Data type

boolean

Trial subjects should be using an adequate method of contraception
Description

contraception

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Psoriasis
Description

Psoriasis

Data type

string

Alias
UMLS CUI
C0033860
SNOMED CT 2010_0731
9014002
MedDRA 13.1
10037153
ICD-10-CM Version 2010
L40
Scalp psoriasis
Description

Scalp psoriasis

Data type

string

Alias
UMLS CUI
C0406326
SNOMED CT 2010_0731
238608008
MedDRA 13.1
10037157
Psoriasis vulgaris
Description

Psoriasis vulgaris

Data type

string

Alias
UMLS CUI
C0263361
MedDRA 13.1
10050576
ICD-10-CM Version 2010
L40.0
Extension
Description

Extension

Data type

string

Alias
UMLS CUI
C0231448
SNOMED CT 2010_0731
255536004
LOINC Version 232
MTHU010348
Disease severity
Description

Severity Code

Data type

string

Alias
UMLS CUI
CL425496
treatment
Description

Therapy

Data type

string

Alias
UMLS CUI
C0039798
radiation
Description

Radiation

Data type

string

Alias
UMLS CUI
C0851346
SNOMED CT 2010_0731
82107009
LOINC Version 232
MTHU026213
PUVA
Description

PUVA

Data type

string

Alias
UMLS CUI
C0853073
MedDRA 13.1
10037580
Rays, Grenz
Description

Grenz ray

Data type

string

Alias
UMLS CUI
C0018233
SNOMED CT 2010_0731
52250000
Ultraviolet B Radiation
Description

UVB

Data type

string

Alias
UMLS CUI
C0564461
SNOMED CT 2010_0731
286632006
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Biological agent
Description

Biological Products

Data type

string

Alias
UMLS CUI
C0005522
SNOMED CT 2010_0731
418980009
Skin care: topical treatments
Description

topical treatment

Data type

string

Alias
UMLS CUI
C0150349
SNOMED CT 2010_0731
386439008
Therapeutic Corticosteroid
Description

corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Psoriasis guttata
Description

guttate psoriasis

Data type

string

Alias
UMLS CUI
C0343052
SNOMED CT 2010_0731
37042000
ICD-10-CM Version 2010
L40.4
pustular psoriasis
Description

pustular psoriasis

Data type

string

Alias
UMLS CUI
C0152081
SNOMED CT 2010_0731
200973000
MedDRA 13.1
10037159
exfoliative psoriasis
Description

erythrodermic psoriasis

Data type

string

Alias
UMLS CUI
C0748052
SNOMED CT 2010_0731
200977004
MedDRA 13.1
10015278
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Atrophic condition of skin
Description

atrophic skin

Data type

string

Alias
UMLS CUI
C0151514
SNOMED CT 2010_0731
400190005
MedDRA 13.1
10040799
ICD-10-CM Version 2010
L90.9
CTCAE Version 4.03
E13714
Renal Insufficiency
Description

renal insufficiency

Data type

string

Alias
UMLS CUI
C1565489
MedDRA 13.1
10022467
Hepatic disorders (SMQ)
Description

hepatic disorders

Data type

string

Alias
UMLS CUI
C1869009
MedDRA 13.1
20000005
Hypercalcemia
Description

hypercalcaemia

Data type

string

Alias
UMLS CUI
C0020437
SNOMED CT 2010_0731
66931009
MedDRA 13.1
10020583
ICD-10-CM Version 2010
E83.52
ICD-9-CM Version 2011
275.42
CTCAE Version 4.03
E12270
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age
Item
18 Years and older
boolean
Scalp psoriasis
Item
Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
boolean
Psoriasis vulgaris
Item
Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
boolean
Extension
Item
Extent of scalp psoriasis involving more than 10% of the total scalp area
boolean
Disease severity
Item
Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity
boolean
Item Group
Exclusion Criteria
PUVA or Grenz ray Radiation therapy
Item
PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
boolean
UVB therapy
Item
UVB therapy anywhere on the patient within 14 days prior to randomisation
boolean
Biologicals
Item
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
boolean
Systemic treatment with effect on scalp psoriasis
Item
Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
boolean
topical treatment for scalp
Item
Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
boolean
Topical treatment with very potent WHO group IV corticosteroids
Item
Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
boolean
Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis
Item
Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
boolean
guttate, pustular, exfoliative or erythrodermic psoriasis
Item
Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
boolean
viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin on the scalp
Item
Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
boolean
renal insufficiency or severe hepatic disorders
Item
Known or suspected severe renal insufficiency or severe hepatic disorders
boolean
clinically significant hypercalcaemia
Item
Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
boolean
contraception
Item
Trial subjects should be using an adequate method of contraception
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Psoriasis
Item
Psoriasis
string
C0033860 (UMLS CUI)
9014002 (SNOMED CT 2010_0731)
10037153 (MedDRA 13.1)
L40 (ICD-10-CM Version 2010)
Scalp psoriasis
Item
Scalp psoriasis
string
C0406326 (UMLS CUI)
238608008 (SNOMED CT 2010_0731)
10037157 (MedDRA 13.1)
Psoriasis vulgaris
Item
Psoriasis vulgaris
string
C0263361 (UMLS CUI)
10050576 (MedDRA 13.1)
L40.0 (ICD-10-CM Version 2010)
Extension
Item
Extension
string
C0231448 (UMLS CUI)
255536004 (SNOMED CT 2010_0731)
MTHU010348 (LOINC Version 232)
Severity Code
Item
Disease severity
string
CL425496 (UMLS CUI)
Therapy
Item
treatment
string
C0039798 (UMLS CUI)
Radiation
Item
radiation
string
C0851346 (UMLS CUI)
82107009 (SNOMED CT 2010_0731)
MTHU026213 (LOINC Version 232)
PUVA
Item
PUVA
string
C0853073 (UMLS CUI)
10037580 (MedDRA 13.1)
Grenz ray
Item
Rays, Grenz
string
C0018233 (UMLS CUI)
52250000 (SNOMED CT 2010_0731)
UVB
Item
Ultraviolet B Radiation
string
C0564461 (UMLS CUI)
286632006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Biological Products
Item
Biological agent
string
C0005522 (UMLS CUI)
418980009 (SNOMED CT 2010_0731)
topical treatment
Item
Skin care: topical treatments
string
C0150349 (UMLS CUI)
386439008 (SNOMED CT 2010_0731)
corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
guttate psoriasis
Item
Psoriasis guttata
string
C0343052 (UMLS CUI)
37042000 (SNOMED CT 2010_0731)
L40.4 (ICD-10-CM Version 2010)
pustular psoriasis
Item
pustular psoriasis
string
C0152081 (UMLS CUI)
200973000 (SNOMED CT 2010_0731)
10037159 (MedDRA 13.1)
erythrodermic psoriasis
Item
exfoliative psoriasis
string
C0748052 (UMLS CUI)
200977004 (SNOMED CT 2010_0731)
10015278 (MedDRA 13.1)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
atrophic skin
Item
Atrophic condition of skin
string
C0151514 (UMLS CUI)
400190005 (SNOMED CT 2010_0731)
10040799 (MedDRA 13.1)
L90.9 (ICD-10-CM Version 2010)
E13714 (CTCAE Version 4.03)
renal insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10022467 (MedDRA 13.1)
hepatic disorders
Item
Hepatic disorders (SMQ)
string
C1869009 (UMLS CUI)
20000005 (MedDRA 13.1)
hypercalcaemia
Item
Hypercalcemia
string
C0020437 (UMLS CUI)
66931009 (SNOMED CT 2010_0731)
10020583 (MedDRA 13.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE Version 4.03)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
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