An interventional study of Colloidal Oatmeal and Topical Cream in Atopic Dermatitis, sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.. Completed at 2 sites in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2012-08-03.
Sponsored by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. · Not applicable, Interventional, and Treatment
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®
Exclusion Criteria:
Experimental Topical cream applied twice daily (or as needed)
Drug: Colloidal Oatmeal
Marketed Topical cream applied twice daily (or as needed)
Device: Topical Cream
Topical cream applied twice daily (or as needed)
Also known as: Not yet marketed
Topical cream applied twice daily (or as needed)
Also known as: EpiCeram
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
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
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
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
| Milestone | 19306-127 | 19306-137 |
|---|---|---|
| Started | 45 | 45 |
| Completed | 41 | 42 |
| Not completed | 4 | 3 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Protocol violation | 1 | 1 |
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
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 3.014 ± 1.9473 | 3.359 ± 3.6925 |
| Day 7, Week 1 | 1.286 ± 1.0137 | 1.621 ± 1.9275 |
| Day 14, Week 2 | 1.310 ± 2.0153 | 1.298 ± 1.5811 |
| Day 21, Week 3 | 1.154 ± 1.1570 | 1.064 ± 1.1320 |
Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
| participants | 19306-127 | 19306-137 |
|---|---|---|
| Improved | 38 ± 1.8789 | 38 ± 2.8447 |
| Not Improved | 3 | 4 |
Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 1.557 ± 2.2526 | 1.208 ± 2.4939 |
| Day 7, Week 1 | 1.840 ± 2.2876 | 1.537 ± 2.2051 |
| Day 14, Week 2 | 2.199 ± 2.4595 | 1.480 ± 2.1464 |
| Day 21, Week 3 | 1.972 ± 2.7890 | 1.685 ± 2.5902 |
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.
| units on a scale | 19306-127 | 19306-137 |
|---|---|---|
| Day 0, Baseline | 2.159 ± 0.6078 | 2.182 ± 0.6567 |
| Day 7, Week 1 | 1.690 ± 0.6803 | 1.667 ± 0.7861 |
| Day 14, Week 2 | 1.585 ± 0.7062 | 1.548 ± 0.8025 |
| Day 21, Week 3 | 1.585 ± 0.8055 | 1.381 ± 0.7949 |
Collected over Three Weeks plus 30 days for Serious Adverse Events. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 19306-127 | — | 0/45 (0%) | 6/45 (13.3%) |
| 19306-137 | — | 0/45 (0%) | 2/45 (4.4%) |
| Event | 19306-127 | 19306-137 |
|---|---|---|
| PRURITUSSkin and subcutaneous tissue disorders | 2/45 | 1/45 |
| PYREXIAGeneral disorders | 2/45 | 0/45 |
| RASH PRURITICSkin and subcutaneous tissue disorders | 1/45 | 0/45 |
| SEASONAL ALLERGYImmune system disorders | 1/45 | 0/45 |
| EAR INFECTIONInfections and infestations | 0/45 | 1/45 |
| Age Continuous(years) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| Mean | 6.9 ± 3.26 | 9.3 ± 4.26 | 8.1 ± 3.96 |
| Sex: Female, Male(Participants) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| Female | 23 | 26 | 49 |
| Male | 22 | 19 | 41 |
| Region of Enrollment(participants) | 19306-127 | 19306-137 | Total |
|---|---|---|---|
| United States | 45 | 45 | 90 |
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.