Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-29

Study Completion Date

2016-02-03

Brief Summary

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The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.

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Detailed Description

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Two groups randomized in a ratio of \[1:1\] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Moisturizer + Body wash

Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)

Group Type EXPERIMENTAL

Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash

Intervention Type OTHER

Body wash

Cetaphil® Restoraderm® body wash (1/day)

Group Type ACTIVE_COMPARATOR

Cetaphil® Restoraderm® body wash

Intervention Type OTHER

Interventions

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Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash

Intervention Type OTHER

Cetaphil® Restoraderm® body wash

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female subject, aged 2 to 12 years inclusive
* Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.

Exclusion Criteria

* Subject presenting bacterial, viral, fungal or parasite skin infection
* Subject with ulcerated lesions, acne or rosacea
* Immunosuppression
* Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor
* Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid
* Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No