Back to resultsEvaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Emollient - Cetaphil Advanced
Sponsored by
About this trial
This is an interventional prevention trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Corticoids, topic, Corticosteroids
Eligibility 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
Sites / Locations
- Hospital Universitário de Brasília
- Complexo Hospitalar Padre Bento de Guarulhos
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Emollient
Arm Description
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Outcomes
Primary Outcome Measures
clinical evaluation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01063218
Brief Title
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Galderma Brasil Ltda.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, Atopic, Corticoids, topic, Corticosteroids
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emollient
Arm Type
Other
Arm Description
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Intervention Type
Other
Intervention Name(s)
Emollient - Cetaphil Advanced
Intervention Description
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
Primary Outcome Measure Information:
Title
clinical evaluation
Time Frame
Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario C Pires, MD
Organizational Affiliation
Complexo Hospitalar Padre Bento de Guarulhos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Izelda Costa, MD
Organizational Affiliation
Hospital Universitário de Brasília
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário de Brasília
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70910-900
Country
Brazil
Facility Name
Complexo Hospitalar Padre Bento de Guarulhos
City
Guarulhos
State/Province
Sao Paulo
ZIP/Postal Code
07051-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
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