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

This study has been completed.
Sponsor:
Information provided by:
Galderma Brasil Ltda.
ClinicalTrials.gov Identifier:
NCT01063218
First received: February 4, 2010
Last updated: March 9, 2012
Last verified: March 2012
History of Changes

February 4, 2010
March 9, 2012
December 2009
September 2010   (final data collection date for primary outcome measure)
clinical evaluation [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01063218 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Dermatitis, Atopic
Other: Emollient - Cetaphil Advanced
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
Emollient
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Intervention: Other: Emollient - Cetaphil Advanced
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
October 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01063218
BR.09.001
No
Mario Cézar Pires, Complexo Hospitalar Padre Bento de Guarulhos
Galderma Brasil Ltda.
Not Provided
Principal Investigator: Mario C Pires, MD Complexo Hospitalar Padre Bento de Guarulhos
Principal Investigator: Izelda Costa, MD Hospital Universitário de Brasília
Galderma Brasil Ltda.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP