Atopic Dermatitis
Conditions
Keywords
eczema
Brief summary
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.
Detailed description
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.
Interventions
DEVICEF# 11054-010
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.
DEVICEF# 10495-053
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.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Post-menarchal female subjects must have a negative urine pregnancy test * Willing to provide written informed consent/assent * Diagnosed as having mild to moderate Atopic Dermatitis (AD) * Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial * Willing to replace their body wash and/or soaps with the one provided in this trial
Exclusion criteria
* Severe AD as determined by the Rajka-Langeland Severity Index * AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial * History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil * Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy * Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | Baseline to Day 43 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | Baseline to Day 15 | 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). |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | Baseline to Day 43 | 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). |
| Itch Score on Day 43 - Change From Baseline | Baseline to Day 43 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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. | 41 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Investigational Device | Atopiclair® Skin and Wound Emulsion | Total |
|---|---|---|---|
| Age, Continuous | 6.37 years STANDARD_DEVIATION 2.9 | 5.56 years STANDARD_DEVIATION 2.84 | 5.96 years STANDARD_DEVIATION 2.88 |
| Region of Enrollment United States | 41 participants | 41 participants | 82 participants |
| Sex: Female, Male Female | 18 Participants | 28 Participants | 46 Participants |
| Sex: Female, Male Male | 23 Participants | 13 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 41 | 12 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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).
Time frame: Baseline to Day 43
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | -4.97 units on a scale | Standard Error 0.41 |
| Atopiclair® Skin and Wound Emulsion | Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline | -5.01 units on a scale | Standard Error 0.4 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.941695% CI: [-1.09, 1.17]Repeated measures ANCOVA
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).
Time frame: Baseline to Day 15
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | -3.79 units on a scale | Standard Error 0.41 |
| Atopiclair® Skin and Wound Emulsion | Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline | -4.14 units on a scale | Standard Error 0.4 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.543195% CI: [-0.78, 1.48]Repeated measures ANCOVA
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).
Time frame: Baseline to Day 43
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | 0.78 units on a scale | Standard Error 0.15 |
| Atopiclair® Skin and Wound Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline | 0.73 units on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.78895% CI: [-0.47, 0.36]ANCOVA
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.
Time frame: Baseline to Day 43
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device | Itch Score on Day 43 - Change From Baseline | -3.26 units on a scale | Standard Error 0.33 |
| Atopiclair® Skin and Wound Emulsion | Itch Score on Day 43 - Change From Baseline | -3.29 units on a scale | Standard Error 0.33 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.950895% CI: [-0.9, 0.96]Repeated measures ANCOVA