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Completed

NCT Number: NCT01326910

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hilltop Research, St. Petersburg, Florida, United States

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About this study

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®

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colloidal Oatmeal

Drug

Topical cream applied twice daily (or as needed)

Other names: Not yet marketed

Topical Cream

Device

Topical cream applied twice daily (or as needed)

Other names: EpiCeram

Primary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: 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 outcomes

  1. Interim Eczema Area and Severity Index (EASI)

    Time frame: 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.

  2. Assessment of Itch

    Time frame: 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

  3. Investigator's Global Atopic Dermatitis Assessment (IGADA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2011
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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