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

Promius Pharma

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Desonide Cream 0.05%; Device: EpiCeram Skin Barrier Emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828412

EPC0801

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

EpiCeram Skin Barrier Emulsion

Treatment:

Device: EpiCeram Skin Barrier Emulsion

2

Active Comparator group

Description:

Desonide Cream 0.05%

Treatment:

Drug: Desonide Cream 0.05%