ID

22438

Description

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

Link

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

Keywords

Versions (2)
  1. 11/25/11 11/25/11 -
  2. 6/4/17 6/4/17 - Martin Dugas
Uploaded on

June 4, 2017

DOI

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License

Creative Commons BY 4.0
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A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

English

Eligibility

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

Inclusion Criteria Healthy volunteers

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1708335
Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
Description

Healthy volunteers 18-65 years

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0001779
UMLS CUI [1,3]
C0232973
Inclusion Criteria Patients with atopic dermatitis
Description

Inclusion Criteria Patients with atopic dermatitis

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

Age 18-65

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Atopic Dermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0011615
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)
Description

At least moderate atopic dermatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011615
UMLS CUI [1,2]
C0205081
Inclusion Criteria Patients with Netherton Syndrome
Description

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
Description

Netherton syndrom, Age 18-65 Years

Data type

boolean

Alias
UMLS CUI [1,1]
C0265962
UMLS CUI [1,2]
C0001779
Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)
Description

confirmed Netherton syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0265962
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
Description

Total lesional sign score

Data type

boolean

Alias
UMLS CUI [1]
C3846158
Exclusion Criteria Healthy volunteers
Description

Exclusion Criteria Healthy volunteers

Alias
UMLS CUI-1
C0680251
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
Description

Allergy to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
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
Description

Other drugs

Data type

boolean

Alias
UMLS CUI [1]
C2729346
Exclusion Criteria Patients with atopic dermatitis
Description

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.
Description

Allergy to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
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
Description

Skin reactivity to UV

Data type

boolean

Alias
UMLS CUI [1,1]
C1154974
UMLS CUI [1,2]
C0205161
Pregnant or nursing (lactating) women
Description

Pregnancy or Lactation

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
Description

Topical eczema treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013595
UMLS CUI [1,2]
C0150349
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.
Description

Recent systemic treatment for atopic dermatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011615
UMLS CUI [1,2]
C1515119
Exclusion Criteria Patients with Netherton Syndrome
Description

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
Description

Allergy to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
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
Description

Skin reactivity to UV

Data type

boolean

Alias
UMLS CUI [1,1]
C1154974
UMLS CUI [1,2]
C0205161
Pregnant or nursing (lactating) women
Description

Pregnancy, Lactation

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Use of topical prescription treatment within 2 week prior to initial dosing of study drug
Description

Topical prescription treatment

Data type

boolean

Alias
UMLS CUI [1]
C0150349
Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
Description

Recent systemic treatment

Data type

boolean

Alias
UMLS CUI [1]
C1515119
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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 Healthy volunteers
C1512693 (UMLS CUI-1)
C1708335 (UMLS CUI-2)
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
C1708335 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0232973 (UMLS CUI [1,3])
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
C0001779 (UMLS CUI [1])
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
C0011615 (UMLS CUI [1])
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
C0011615 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
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
C0265962 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
confirmed Netherton syndrome
Item
Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin)
boolean
C0265962 (UMLS CUI [1])
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
C3846158 (UMLS CUI [1])
Item Group
Exclusion Criteria Healthy volunteers
C0680251 (UMLS CUI-1)
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
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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
C2729346 (UMLS CUI [1])
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
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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
C1154974 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Pregnancy or Lactation
Item
Pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Contraception
Item
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
boolean
C0700589 (UMLS CUI [1])
Topical eczema treatment
Item
Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
boolean
C0013595 (UMLS CUI [1,1])
C0150349 (UMLS CUI [1,2])
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
C0011615 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
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
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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
C1154974 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Pregnancy, Lactation
Item
Pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Contraception
Item
Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
boolean
C0700589 (UMLS CUI [1])
Topical prescription treatment
Item
Use of topical prescription treatment within 2 week prior to initial dosing of study drug
boolean
C0150349 (UMLS CUI [1])
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
C1515119 (UMLS CUI [1])
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