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
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Other: Emollient - Cetaphil Advanced
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Galderma Brasil Ltda.:

Primary Outcome Measures:
  • clinical evaluation [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 4, 2010
Last Updated: March 9, 2012
Health Authority: Brazil: ANVISA and Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014