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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Device: Topical Cream; Drug: Colloidal Oatmeal

• Registration Number: NCT01326910
• Lead Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Brief 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.

Detailed 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®

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-06
• Results First Submitted: 2012-06-27
• Results First Submitted QC: 2012-06-27
• Last Update Submitted: 2012-06-27
• Results First Posted: 2012-08-03
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
19306-137	Topical Cream	Marketed Topical cream applied twice daily (or as needed)
19306-127	Colloidal Oatmeal	Experimental Topical cream applied twice daily (or as needed)

Primary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI)	3 weeks	A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72

Secondary Outcome Measures

Name	Time	Method
Interim Eczema Area and Severity Index (EASI)	Week 2	Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Assessment of Itch	through Week 3	Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Investigator's Global Atopic Dermatitis Assessment (IGADA)	through Week 3	An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.

Trial Locations

Locations (1)

Hilltop Research; 🇺🇸 Miamiville, Ohio, United States