We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01063218
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : March 12, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: Emollient - Cetaphil Advanced Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
Study Start Date : December 2009
Primary Completion Date : September 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids
Drug Information available for: Cetaphil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. clinical evaluation [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063218


Locations
Brazil
Hospital Universitário de Brasília
Brasília, Distrito Federal, Brazil, 70910-900
Complexo Hospitalar Padre Bento de Guarulhos
Guarulhos, Sao Paulo, Brazil, 07051-000
Sponsors and Collaborators
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
More Information

Responsible Party: Mario Cézar Pires, Complexo Hospitalar Padre Bento de Guarulhos
ClinicalTrials.gov Identifier: NCT01063218     History of Changes
Other Study ID Numbers: BR.09.001
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Galderma Brasil Ltda.:
Dermatitis, Atopic
Corticoids, topic
Corticosteroids

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents