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

Atopic Dermatitis Clinical Trial

Official title:

A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326910
• Other study ID #: COOADM3002
• Secondary ID: HTR 11-130435-11
• Status: Completed
• Phase: N/A
• First received: March 30, 2011
• Last updated: June 27, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Colloidal Oatmeal
Topical cream applied twice daily (or as needed)

Device:
• Topical Cream
Topical cream applied twice daily (or as needed)

Locations

Country	Name	City	State
United States	Hilltop Research	Miamiville	Ohio
United States	Hilltop Research	St Petersburg	Florida

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Area and Severity Index (EASI)	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	3 weeks	No
Secondary	Interim Eczema Area and Severity Index (EASI)	Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.	Week 2	No
Secondary	Assessment of Itch	Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable	through Week 3	No
Secondary	Investigator's Global Atopic Dermatitis Assessment (IGADA)	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.	through Week 3	No