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| ID | Type | Description | Link |
|---|---|---|---|
| HTR 11-130435-111 | Other Identifier | CRO |
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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®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19306-127 | Experimental | Experimental Topical cream applied twice daily (or as needed) |
|
| 19306-137 | Other | Marketed Topical cream applied twice daily (or as needed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colloidal Oatmeal | Drug | Topical cream applied twice daily (or as needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assessment of Itch |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, MD, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hilltop Research | St. Petersburg | Florida | 33710 | United States | ||
| Hilltop Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28366039 | Derived | Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 19306-127 | Experimental Topical cream applied twice daily (or as needed) |
| FG001 | 19306-137 | Marketed Topical cream applied twice daily (or as needed) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 19306-127 | Experimental Topical cream applied twice daily (or as needed) |
| BG001 | 19306-137 | Marketed Topical cream applied twice daily (or as needed) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
Three Weeks plus 30 days for Serious Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 19306-127 | Experimental Topical cream applied twice daily (or as needed) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, Sr. Specialist Clinical Quality Systems and Process | Johnson & Johnson Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Topical Cream | Device | Topical cream applied twice daily (or as needed) |
|
|
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 |
| 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 |
| Miamiville |
| Ohio |
| 45147 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Intention to Treat | Posted | Number | participants | Week 2 |
|
|
|
| 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 | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | through Week 3 |
|
|
|
| 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. | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | through Week 3 |
|
|
|
| 0 |
| 45 |
| 6 |
| 45 |
| EG001 | 19306-137 | Marketed Topical cream applied twice daily (or as needed) | 0 | 45 | 2 | 45 |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
The trial was conducted as work made for hire, and disclosure of results by the investigator is prohibited without the prior written consent of Sponsor.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Day 14, Week 2 |
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| Day 21, Week 3 |
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| Day 14, Week 2 |
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| Day 21, Week 3 |
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