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:
Galderma Brasil Ltda.
Information provided by:
Galderma Brasil Ltda.
ClinicalTrials.gov Identifier:
NCT01063218
First received: February 4, 2010
Last updated: March 9, 2012
Last verified: March 2012
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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
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 May 22, 2013