- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063218
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
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Distrito Federal
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Brasília, Distrito Federal, Brazil, 70910-900
- Hospital Universitário de Brasília
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Sao Paulo
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Guarulhos, Sao Paulo, Brazil, 07051-000
- Complexo Hospitalar Padre Bento de Guarulhos
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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
|
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
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
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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