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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier:
NCT01326910
First received: March 30, 2011
Last updated: June 27, 2012
Last verified: June 2012

March 30, 2011
June 27, 2012
March 2011
May 2011   (final data collection date for primary outcome measure)
Eczema Area and Severity Index (EASI) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01326910 on ClinicalTrials.gov Archive Site
  • Interim Eczema Area and Severity Index (EASI) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
    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) [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
    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.
  • Interim Eczema Area and Severity Index (EASI) [ Time Frame: through Week 2 ] [ Designated as safety issue: No ]
    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
  • Assessment of Itch [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
    Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS)
  • Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
    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 clear, almost clear, mild, moderate, severe, or very severe.
Not Provided
Not Provided
 
Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
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

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.

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®

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: Colloidal Oatmeal
    Topical cream applied twice daily (or as needed)
    Other Name: Not yet marketed
  • Device: Topical Cream
    Topical cream applied twice daily (or as needed)
    Other Name: EpiCeram
  • Experimental: 19306-127
    Experimental Topical cream applied twice daily (or as needed)
    Intervention: Drug: Colloidal Oatmeal
  • 19306-137
    Marketed Topical cream applied twice daily (or as needed)
    Intervention: Device: Topical Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01326910
COOADM3002, HTR 11-130435-111
No
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Not Provided
Study Director: Qing Li, MD, PhD Johnson & Johnson Consumer and Personal Products Worldwide
Johnson & Johnson Consumer and Personal Products Worldwide
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP