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The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.
This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 11054-010 | Experimental | F# 11054-010 Investigational Device |
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| 10495-053 | Active Comparator | F# 10495-053 Atopiclair |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F# 11054-010 | Device | Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | Baseline to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | Baseline to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, PhD | Johnson & Johnson Consumer and Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens & Associates, Inc | Colorado Springs | Colorado | 80915 | United States | ||
| Academic Dermatology Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device | Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. |
| FG001 | Atopiclair® Skin and Wound Emulsion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| F# 10495-053 | Device | Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of study. Massage gently into skin. |
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| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). | Baseline to Day 43 |
| Itch Score on Day 43 - Change From Baseline | The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable. | Baseline to Day 43 |
| Albuquerque |
| New Mexico |
| 87106 |
| United States |
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. |
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| NOT COMPLETED |
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All randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Device | Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. |
| BG001 | Atopiclair® Skin and Wound Emulsion | Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 43 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 15 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 43 |
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| Secondary | Itch Score on Day 43 - Change From Baseline | The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Day 43 |
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Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
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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 | Investigational Device | Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. | 0 | 41 | 15 | 41 | ||
| EG001 | Atopiclair® Skin and Wound Emulsion | Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. | 0 | 41 | 12 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Irritation | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Application Site Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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Investigators agreed not to publish the study results without prior sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amisha Parikh-Das, PhD/Study Director | Johnson & Johnson Consumer Inc | 973 385-2863 USA EST | AParikh1@its.jnj.com |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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