ID

11638

Beschrijving

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis ODM derived from http://clinicaltrials.gov/ct2/show/NCT00148213?term=NCT00148213&rank=1

Link

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

Trefwoorden

Versies (2)
  1. 24-11-11 24-11-11 -
  2. 09-07-15 09-07-15 - Martin Dugas
Geüploaded op

9 juli 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Psoriasis NCT00216879

Engels

Eligibility Psoriasis NCT00216879

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Psoriasis NCT00216879
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
18 Years and older
Beschrijving

18 Years and older

Datatype

boolean

Alias
UMLS CUI-1
C0001779
Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0406326
Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0263361
Extent of scalp psoriasis involving more than 10% of the total scalp area
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0439792
Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0521117
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0853073
UMLS CUI-2
C0018233
UVB therapy anywhere on the patient within 14 days prior to randomisation
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0564461
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0005522
Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C1515119
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0150349
Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0150349
UMLS CUI-2
C0001617
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C2347852
Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
Beschrijving

Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis

Datatype

boolean

Alias
UMLS CUI-1
C0343052
UMLS CUI-2
C0152081
UMLS CUI-3
C0748052
Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0037278
Known or suspected severe renal insufficiency or severe hepatic disorders
Beschrijving

Known or suspected severe renal insufficiency or severe hepatic disorders

Datatype

boolean

Alias
UMLS CUI-1
C1565489
UMLS CUI-2
C1869009
Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI-1
C0020437
Trial subjects should be using an adequate method of contraception
Beschrijving

Trial subjects should be using an adequate method of contraception

Datatype

boolean

Alias
UMLS CUI-1
C0700589
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Similar models

Eligibility Psoriasis NCT00216879

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Psoriasis NCT00216879
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
Scalp psoriasis
Item
Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
boolean
C0406326 (UMLS CUI-1)
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
C0263361 (UMLS CUI-1)
Extent
Item
Extent of scalp psoriasis involving more than 10% of the total scalp area
boolean
C0439792 (UMLS CUI-1)
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
C0521117 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
PUVA or Grenz ray Radiation therapy
Item
PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
boolean
C0853073 (UMLS CUI-1)
C0018233 (UMLS CUI-2)
UVB therapy
Item
UVB therapy anywhere on the patient within 14 days prior to randomisation
boolean
C0564461 (UMLS CUI-1)
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
C0005522 (UMLS CUI-1)
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
C1515119 (UMLS CUI-1)
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
C0150349 (UMLS CUI-1)
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
C0150349 (UMLS CUI-1)
C0001617 (UMLS CUI-2)
concomitant medication
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
C2347852 (UMLS CUI-1)
guttate, pustular, exfoliative or erythrodermic psoriasis
Item
Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
boolean
C0343052 (UMLS CUI-1)
C0152081 (UMLS CUI-2)
C0748052 (UMLS CUI-3)
skin infection
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
C0037278 (UMLS CUI-1)
renal insufficiency or severe hepatic disorders
Item
Known or suspected severe renal insufficiency or severe hepatic disorders
boolean
C1565489 (UMLS CUI-1)
C1869009 (UMLS CUI-2)
hypercalcaemia
Item
Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
boolean
C0020437 (UMLS CUI-1)
contraception
Item
Trial subjects should be using an adequate method of contraception
boolean
C0700589 (UMLS CUI-1)
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