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
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Drug: Colloidal Oatmeal
Device: Topical Cream

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 90
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 19306-127
Experimental Topical cream applied twice daily (or as needed)
Drug: Colloidal Oatmeal
Topical cream applied twice daily (or as needed)
Other Name: Not yet marketed
19306-137
Marketed Topical cream applied twice daily (or as needed)
Device: Topical Cream
Topical cream applied twice daily (or as needed)
Other Name: EpiCeram

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®

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326910

Locations
United States, Florida
Hilltop Research
St Petersburg, Florida, United States, 33710
United States, Ohio
Hilltop Research
Miamiville, Ohio, United States, 45147
Sponsors and Collaborators
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Investigators
Study Director: Qing Li, MD, PhD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: COOADM3002, HTR 11-130435-111
Study First Received: March 30, 2011
Results First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014