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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-10-31

Brief Summary

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The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Emollient

Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day

Group Type OTHER

Emollient - Cetaphil Advanced

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or Female patients
* 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 presenting any serious systemic disease
* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma Brasil Ltda.

INDUSTRY

Sponsor Role lead

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

Site Status

Complexo Hospitalar Padre Bento de Guarulhos

Guarulhos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BR.09.001

Identifier Type: -

Identifier Source: org_study_id

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