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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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Galderma

Status and phase

Completed
Phase 4

Conditions

Dermatitis, Atopic

Treatments

Other: Emollient - Cetaphil Advanced

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063218
BR.09.001

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

2 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

74 participants in 1 patient group

Emollient
Other group
Description:
Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day
Treatment:
Other: Emollient - Cetaphil Advanced

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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