Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

Johnson & Johnson (J&J)

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Device: Topical Cream; Drug: Colloidal Oatmeal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326910

HTR 11-130435-111 (Other Identifier)

COOADM3002

Details and patient eligibility

About

This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Full description

The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Enrollment: 90 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children ages 6 mo- 18 years
• Any ethnicity
• Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
• Mild to moderate atopic dermatitis per Rajka-Langeland severity index
• Willing to use only provided cream and body wash for duration of study

Exclusion criteria

• Known sensitivity to investigational products
• Pregnant or breastfeeding
• Severe AD per Rajka-Langeland severity index
• AD requiring class I (super potent) or class II or III (potent) topical steroids
• Requires greater than 2.0 g inhaled or intranasal corticosteroids
• Other skin conditions which may interfere with the scoring of AD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

19306-127

Experimental group

Description:

Experimental Topical cream applied twice daily (or as needed)

Treatment:

Drug: Colloidal Oatmeal

19306-137

Other group

Description:

Marketed Topical cream applied twice daily (or as needed)

Treatment:

Device: Topical Cream