ID

116

Beschreibung

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT01428297

Link

http://clinicaltrials.gov/ct2/show/record/NCT01428297

Stichworte

Versionen (2)
  1. 25.11.11 25.11.11 -
  2. 04.06.17 04.06.17 - Martin Dugas
Hochgeladen am

25. November 2011

DOI

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Eligibility NCT01428297 Atopic Dermatitis

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria Healthy volunteers
Beschreibung

Inclusion Criteria Healthy volunteers

Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
Beschreibung

Healthy volunteers 18-65 years

Datentyp

boolean

Inclusion Criteria Patients with atopic dermatitis
Beschreibung

Inclusion Criteria Patients with atopic dermatitis

Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
Beschreibung

Age 18-65

Datentyp

boolean

Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following: 1. History of involvement of the skin creases 2. Personal history of asthma or hay fever 3. History of generally dry skin in the past year 4. Onset before age of 2 years 5. Visible flexural dermatitis
Beschreibung

Atopic Dermatitis

Datentyp

boolean

Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
Beschreibung

At least moderate atopic dermatitis

Datentyp

boolean

Inclusion Criteria Patients with Netherton Syndrome
Beschreibung

Inclusion Criteria Patients with Netherton Syndrome

Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
Beschreibung

Netherton syndrom, Age 18-65 Years

Datentyp

boolean

Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)
Beschreibung

confirmed Netherton syndrome

Datentyp

boolean

Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline
Beschreibung

Total lesional sign score

Datentyp

boolean

Exclusion Criteria Healthy volunteers
Beschreibung

Exclusion Criteria Healthy volunteers

History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
Beschreibung

Allergy to study drug

Datentyp

boolean

Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
Beschreibung

Other drugs

Datentyp

boolean

Exclusion Criteria Patients with atopic dermatitis
Beschreibung

Exclusion Criteria Patients with atopic dermatitis

History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
Beschreibung

Allergy to study drug

Datentyp

boolean

History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
Beschreibung

Skin reactivity to UV

Datentyp

boolean

Pregnant or nursing (lactating) women
Beschreibung

Pregnancy, Lactation

Datentyp

boolean

Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Beschreibung

Contraception

Datentyp

boolean

Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
Beschreibung

Topical eczema treatment

Datentyp

boolean

Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
Beschreibung

Recent systemic treatment for atopic dermatitis

Datentyp

boolean

Exclusion Criteria Patients with Netherton Syndrome
Beschreibung

Exclusion Criteria Patients with Netherton Syndrome

History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction
Beschreibung

Allergy to study drug

Datentyp

boolean

History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
Beschreibung

Skin reactivity to UV

Datentyp

boolean

Pregnant or nursing (lactating) women
Beschreibung

Pregnancy, Lactation

Datentyp

boolean

Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Beschreibung

Contraception

Datentyp

boolean

Use of topical prescription treatment within 2 week prior to initial dosing of study drug
Beschreibung

Topical prescription treatment

Datentyp

boolean

Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
Beschreibung

Recent systemic treatment

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Healthy Subject
Beschreibung

Healthy Volunteer

Datentyp

string

Alias
UMLS CUI
C1708335
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Dermatitis, Atopic
Beschreibung

Atopic eczema

Datentyp

string

Alias
UMLS CUI
C0011615
SNOMED CT 2010_0731
24079001
MedDRA 13.1
10012434
ICD-10-CM Version 2010
L20
Pruritus
Beschreibung

Itchy skin

Datentyp

string

Alias
UMLS CUI
C0033774
SNOMED CT 2010_0731
418363000
MedDRA 13.1
10037087
ICD-10-CM Version 2010
L29
ICD-9-CM Version 2011
698.9
CTCAE Version 4.03
E13686
Skin crease
Beschreibung

Skin crease

Datentyp

string

Alias
UMLS CUI
C0459397
SNOMED CT 2010_0731
280385004
Asthma
Beschreibung

Bronchial Asthma

Datentyp

string

Alias
UMLS CUI
C0004096
SNOMED CT 2010_0731
195967001
MedDRA 13.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
Hay fever (Seasonal Allergy)
Beschreibung

Allergic rhinitis due to pollen

Datentyp

string

Alias
UMLS CUI
C0018621
SNOMED CT 2010_0731
367498001
MedDRA 13.1
10048908
ICD-10-CM Version 2010
J30.1
ICD-9-CM Version 2011
477.0
Dry skin
Beschreibung

Dry skin

Datentyp

string

Alias
UMLS CUI
C0151908
SNOMED CT 2010_0731
16386004
MedDRA 13.1
10013786
CTCAE Version 4.03
E13623
Onset
Beschreibung

Onset

Datentyp

string

Alias
UMLS CUI
C0332162
SNOMED CT 2010_0731
77374008
Flexural eczema
Beschreibung

Flexural atopic dermatitis

Datentyp

string

Alias
UMLS CUI
C0263224
SNOMED CT 2010_0731
402183009
MedDRA 13.1
10016775
ICD-10-CM Version 2010
L20.82
Allergic reaction, due to correct medicinal substance properly administered
Beschreibung

Allergic reaction, due to correct medicinal substance properly administered

Datentyp

string

Alias
UMLS CUI
C0274302
SNOMED CT 2010_0731
57302007
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Dietary Supplements
Beschreibung

Nutritional supplement

Datentyp

string

Alias
UMLS CUI
C0242295
SNOMED CT 2010_0731
108961000
LOINC Version 232
MTHU035664
Ultraviolet Rays
Beschreibung

UV

Datentyp

string

Alias
UMLS CUI
C0041625
SNOMED CT 2010_0731
41355003
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Topical Corticosteroid
Beschreibung

Topical Corticosteroid

Datentyp

string

Alias
UMLS CUI
C0304604
SNOMED CT 2010_0731
331645009
Phototherapy
Beschreibung

Light therapy

Datentyp

string

Alias
UMLS CUI
C0031765
SNOMED CT 2010_0731
31394004
MedDRA 13.1
10063925
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria Healthy volunteers
Healthy volunteers 18-65 years
Item
Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
boolean
Item Group
Inclusion Criteria Patients with atopic dermatitis
Age 18-65
Item
Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
boolean
Atopic Dermatitis
Item
Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following: 1. History of involvement of the skin creases 2. Personal history of asthma or hay fever 3. History of generally dry skin in the past year 4. Onset before age of 2 years 5. Visible flexural dermatitis
boolean
At least moderate atopic dermatitis
Item
Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
boolean
Item Group
Inclusion Criteria Patients with Netherton Syndrome
Netherton syndrom, Age 18-65 Years
Item
Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
boolean
confirmed Netherton syndrome
Item
Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)
boolean
Total lesional sign score
Item
Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline
boolean
Item Group
Exclusion Criteria Healthy volunteers
Allergy to study drug
Item
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
boolean
Other drugs
Item
Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
boolean
Item Group
Exclusion Criteria Patients with atopic dermatitis
Allergy to study drug
Item
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
boolean
Skin reactivity to UV
Item
History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
boolean
Pregnancy, Lactation
Item
Pregnant or nursing (lactating) women
boolean
Contraception
Item
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
boolean
Topical eczema treatment
Item
Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
boolean
Recent systemic treatment for atopic dermatitis
Item
Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
boolean
Item Group
Exclusion Criteria Patients with Netherton Syndrome
Allergy to study drug
Item
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction
boolean
Skin reactivity to UV
Item
History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds
boolean
Pregnancy, Lactation
Item
Pregnant or nursing (lactating) women
boolean
Contraception
Item
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
boolean
Topical prescription treatment
Item
Use of topical prescription treatment within 2 week prior to initial dosing of study drug
boolean
Recent systemic treatment
Item
Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Healthy Volunteer
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Atopic eczema
Item
Dermatitis, Atopic
string
C0011615 (UMLS CUI)
24079001 (SNOMED CT 2010_0731)
10012434 (MedDRA 13.1)
L20 (ICD-10-CM Version 2010)
Itchy skin
Item
Pruritus
string
C0033774 (UMLS CUI)
418363000 (SNOMED CT 2010_0731)
10037087 (MedDRA 13.1)
L29 (ICD-10-CM Version 2010)
698.9 (ICD-9-CM Version 2011)
E13686 (CTCAE Version 4.03)
Skin crease
Item
Skin crease
string
C0459397 (UMLS CUI)
280385004 (SNOMED CT 2010_0731)
Bronchial Asthma
Item
Asthma
string
C0004096 (UMLS CUI)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Allergic rhinitis due to pollen
Item
Hay fever (Seasonal Allergy)
string
C0018621 (UMLS CUI)
367498001 (SNOMED CT 2010_0731)
10048908 (MedDRA 13.1)
J30.1 (ICD-10-CM Version 2010)
477.0 (ICD-9-CM Version 2011)
Dry skin
Item
Dry skin
string
C0151908 (UMLS CUI)
16386004 (SNOMED CT 2010_0731)
10013786 (MedDRA 13.1)
E13623 (CTCAE Version 4.03)
Onset
Item
Onset
string
C0332162 (UMLS CUI)
77374008 (SNOMED CT 2010_0731)
Flexural atopic dermatitis
Item
Flexural eczema
string
C0263224 (UMLS CUI)
402183009 (SNOMED CT 2010_0731)
10016775 (MedDRA 13.1)
L20.82 (ICD-10-CM Version 2010)
Allergic reaction, due to correct medicinal substance properly administered
Item
Allergic reaction, due to correct medicinal substance properly administered
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Nutritional supplement
Item
Dietary Supplements
string
C0242295 (UMLS CUI)
108961000 (SNOMED CT 2010_0731)
MTHU035664 (LOINC Version 232)
UV
Item
Ultraviolet Rays
string
C0041625 (UMLS CUI)
41355003 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Topical Corticosteroid
Item
Topical Corticosteroid
string
C0304604 (UMLS CUI)
331645009 (SNOMED CT 2010_0731)
Light therapy
Item
Phototherapy
string
C0031765 (UMLS CUI)
31394004 (SNOMED CT 2010_0731)
10063925 (MedDRA 13.1)
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