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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Criteria

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