Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
This study has been completed.
Sponsor:
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
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
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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
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 June 18, 2013