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

Phase 4

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Other: Emollient - Cetaphil Advanced

• Registration Number: NCT01063218
• Lead Sponsor: Galderma Brasil Ltda.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-09
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Emollient	Emollient - Cetaphil Advanced	Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day

Primary Outcome Measures

Name	Time	Method
clinical evaluation	Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24

Trial Locations

Locations (2)

Hospital Universitário de Brasília; 🇧🇷 Brasília, Distrito Federal, Brazil

Complexo Hospitalar Padre Bento de Guarulhos; 🇧🇷 Guarulhos, Sao Paulo, Brazil