Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-08-31

Brief Summary

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This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

EpiCeram Skin Barrier Emulsion

Group Type ACTIVE_COMPARATOR

EpiCeram Skin Barrier Emulsion

Intervention Type DEVICE

topical cream, twice daily, 6 weeks

2

Desonide Cream 0.05%

Group Type ACTIVE_COMPARATOR

Desonide Cream 0.05%

Intervention Type DRUG

topical cream, twice daily, 6 weeks

Interventions

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EpiCeram Skin Barrier Emulsion

topical cream, twice daily, 6 weeks

Intervention Type DEVICE

Desonide Cream 0.05%

topical cream, twice daily, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* at least 3 months of age and less than 13 years of age
* atopic dermatitis of moderate severity

Exclusion Criteria

* pregnant or lactating
* treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
* treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
* serious or uncontrolled medical condition
* active infection
* significant use of inhaled, intranasal, or intraocular corticosteroid

Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No