Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
NCT ID: NCT01063218
Last Updated: 2012-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2009-12-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Emollient
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Emollient - Cetaphil Advanced
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
Interventions
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Emollient - Cetaphil Advanced
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
Eligibility Criteria
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Inclusion Criteria
* 2 to 10 years old.
* with light to moderate with no signs of acute/ sub-acute eczema or in activity.
* Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
* Subjects can present light to moderate dryness.
Exclusion Criteria
* Subjects with medical history regarding serious asthma
* Subjects with known or suspected allergy to one of the investigational products
* Subjects with acute atopic eczema or in activity, needing systemic antibiotics
* Subjects with signs of active infections on skin
* Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
* Female subjects who are not in pre-menarche period.
* Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
* Patient with a wash-out period for treatment less than:
* injectable corticoids: 60 days
* systemic corticoids: 15 days
* topic corticoids: 8 days
* topic immunomodulator: 8 days
* antihistaminic : 48 hours
2 Years
10 Years
ALL
Yes
Sponsors
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Galderma Brasil Ltda.
INDUSTRY
Responsible Party
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Complexo Hospitalar Padre Bento de Guarulhos
Principal Investigators
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Mario C Pires, MD
Role: PRINCIPAL_INVESTIGATOR
Complexo Hospitalar Padre Bento de Guarulhos
Izelda Costa, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitário de Brasília
Locations
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Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Complexo Hospitalar Padre Bento de Guarulhos
Guarulhos, São Paulo, Brazil
Countries
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Other Identifiers
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BR.09.001
Identifier Type: -
Identifier Source: org_study_id
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