Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application

March 9, 2012 updated by: Galderma Brasil Ltda.

Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70910-900
        • Hospital Universitário de Brasília
    • Sao Paulo
      • Guarulhos, Sao Paulo, Brazil, 07051-000
        • Complexo Hospitalar Padre Bento de Guarulhos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Emollient
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Other: Emollient - Cetaphil Advanced
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical evaluation
Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma Brasil Ltda.

Investigators

  • Principal Investigator: Mario C Pires, MD, Complexo Hospitalar Padre Bento de Guarulhos
  • Principal Investigator: Izelda Costa, MD, Hospital Universitário de Brasília

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR.09.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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