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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01063218
Enrollment
74
Registered
2010-02-05
Start date
2009-12-31
Completion date
2010-10-31
Last updated
2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic, Corticoids, topic, Corticosteroids

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.

Interventions

OTHEREmollient - Cetaphil Advanced

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

Sponsors

Galderma Brasil Ltda.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
clinical evaluationBaseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026