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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063218
• Other study ID #: BR.09.001
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2010
• Last updated: March 9, 2012
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: March 2012
• Source: Galderma Brasil Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasília	Brasília	Distrito Federal
Brazil	Complexo Hospitalar Padre Bento de Guarulhos	Guarulhos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Brasil Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical evaluation		Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24	Yes