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

NCT01063218 | Completed Phase 4

• 1 other identifier: BR.09.001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic; Corticoids, topic; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• clinical evaluation

  Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24

Study Arms (1)

Emollient

OTHER

Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day

Other: Emollient - Cetaphil Advanced

Interventions

Emollient - Cetaphil Advanced OTHER

Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.

Emollient

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or Female patients
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma Brasil Ltda.: lead

Study Sites (2)

Hospital Universitário de Brasília

Brasília, Federal District, 70910-900, Brazil

Location

Complexo Hospitalar Padre Bento de Guarulhos

Guarulhos, São Paulo, 07051-000, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mario C Pires, MD

  Complexo Hospitalar Padre Bento de Guarulhos

  PRINCIPAL INVESTIGATOR

• Izelda Costa, MD

  Hospital Universitário de Brasília

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

BR (2)