Atopic Dermatitis
Conditions
Keywords
Eczema
Brief summary
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.
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®
Interventions
Topical cream applied twice daily (or as needed)
DEVICETopical Cream
Topical cream applied twice daily (or as needed)
Sponsors
Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 3 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Interim Eczema Area and Severity Index (EASI) | Week 2 | 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 | through Week 3 | 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) | through Week 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 19306-127 Experimental Topical cream applied twice daily (or as needed) | 45 |
| 19306-137 Marketed Topical cream applied twice daily (or as needed) | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| Age Continuous | 6.9 years STANDARD_DEVIATION 3.26 | 9.3 years STANDARD_DEVIATION 4.26 | 8.1 years STANDARD_DEVIATION 3.96 |
| Region of Enrollment United States | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 45 | 2 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
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
Time frame: 3 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 19306-127 | Eczema Area and Severity Index (EASI) | Day 0, Baseline | 3.014 units on a scale | Standard Deviation 1.9473 |
| 19306-127 | Eczema Area and Severity Index (EASI) | Day 14, Week 2 | 1.310 units on a scale | Standard Deviation 2.0153 |
| 19306-127 | Eczema Area and Severity Index (EASI) | Day 7, Week 1 | 1.286 units on a scale | Standard Deviation 1.0137 |
| 19306-127 | Eczema Area and Severity Index (EASI) | Day 21, Week 3 | 1.154 units on a scale | Standard Deviation 1.157 |
| 19306-137 | Eczema Area and Severity Index (EASI) | Day 7, Week 1 | 1.621 units on a scale | Standard Deviation 1.9275 |
| 19306-137 | Eczema Area and Severity Index (EASI) | Day 0, Baseline | 3.359 units on a scale | Standard Deviation 3.6925 |
| 19306-137 | Eczema Area and Severity Index (EASI) | Day 21, Week 3 | 1.064 units on a scale | Standard Deviation 1.132 |
| 19306-137 | Eczema Area and Severity Index (EASI) | Day 14, Week 2 | 1.298 units on a scale | Standard Deviation 1.5811 |
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
Time frame: through Week 3
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 19306-127 | Assessment of Itch | Day 0, Baseline | 1.557 units on a scale | Standard Deviation 2.2526 |
| 19306-127 | Assessment of Itch | Day 7, Week 1 | 1.840 units on a scale | Standard Deviation 2.2876 |
| 19306-127 | Assessment of Itch | Day 14, Week 2 | 2.199 units on a scale | Standard Deviation 2.4595 |
| 19306-127 | Assessment of Itch | Day 21, Week 3 | 1.972 units on a scale | Standard Deviation 2.789 |
| 19306-137 | Assessment of Itch | Day 21, Week 3 | 1.685 units on a scale | Standard Deviation 2.5902 |
| 19306-137 | Assessment of Itch | Day 0, Baseline | 1.208 units on a scale | Standard Deviation 2.4939 |
| 19306-137 | Assessment of Itch | Day 14, Week 2 | 1.480 units on a scale | Standard Deviation 2.1464 |
| 19306-137 | Assessment of Itch | Day 7, Week 1 | 1.537 units on a scale | Standard Deviation 2.2051 |
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.
Time frame: Week 2
Population: Intention to Treat
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 19306-127 | Interim Eczema Area and Severity Index (EASI) | Improved | 38 participants | 1.8789 |
| 19306-127 | Interim Eczema Area and Severity Index (EASI) | Not Improved | 3 participants | — |
| 19306-137 | Interim Eczema Area and Severity Index (EASI) | Improved | 38 participants | 2.8447 |
| 19306-137 | Interim Eczema Area and Severity Index (EASI) | Not Improved | 4 participants | — |
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.
Time frame: through Week 3
Population: Intention to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 19306-127 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 0, Baseline | 2.159 units on a scale | Standard Deviation 0.6078 |
| 19306-127 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 7, Week 1 | 1.690 units on a scale | Standard Deviation 0.6803 |
| 19306-127 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 14, Week 2 | 1.585 units on a scale | Standard Deviation 0.7062 |
| 19306-127 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 21, Week 3 | 1.585 units on a scale | Standard Deviation 0.8055 |
| 19306-137 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 21, Week 3 | 1.381 units on a scale | Standard Deviation 0.7949 |
| 19306-137 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 0, Baseline | 2.182 units on a scale | Standard Deviation 0.6567 |
| 19306-137 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 14, Week 2 | 1.548 units on a scale | Standard Deviation 0.8025 |
| 19306-137 | Investigator's Global Atopic Dermatitis Assessment (IGADA) | Day 7, Week 1 | 1.667 units on a scale | Standard Deviation 0.7861 |