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The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.
At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Tolerance Assessment | Experimental | Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin |
|
| Baby (infants, toddlers, young children) Tolerance Assessment | Experimental | Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Product | Drug | 1% Colloidal Oatmeal Balm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage With Erythema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Erythema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Erythema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Erythema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Erythema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Erythema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline after investigational product application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amisha Parikh-Das, Ph.D. | Johnson & Johnson Consumer Inc. (J&JCI) | Study Director |
| Daniel Hogan, M.D. | Hill-top Research Inc. | Principal Investigator |
| Ethlynn Schorr, M.D. | TKL Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill-top Research, Inc | St. Petersburg | Florida | 33714 | United States | ||
| TKL Research Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults | Adults - 1% Colloidal Oatmeal Balm |
| FG001 | Babies | Babies - 1% Colloidal Oatmeal Balm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults | Adults - 1% Colloidal Oatmeal Balm |
| BG001 | Babies | Babies - 1% Colloidal Oatmeal Balm |
| 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 | Percentage With Erythema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
Day 14 ± 2 days, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 5 (Day 14 ± 2 days). 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 | Adults | Adults - 1% Colloidal Oatmeal Balm |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amisha Parikh-Das, PhD/Study Director | Johnson & Johnson Consumer Inc. | 973-255-8701 USA EST | AParikh1@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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| At baseline after investigational product application |
| Percentage With Erythema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Erythema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Erythema on the Face at Day 1 | Percentage of adults and babies with erythema on the face at Day 1 | At Day 1 |
| Percentage With Erythema on the Arms at Day 1 | Percentage of adults and babies with erythema on the arms at Day 1 | At Day 1 |
| Percentage With Erythema on the Legs at Day 1 | Percentage of adults and babies with erythema on the legs at Day 1 | At Day 1 |
| Percentage With Erythema on the Torso at Day 1 | Percentage of adults and babies with erythema on the torso at Day 1 | At Day 1 |
| Percentage With Erythema on the Face at Day 7 | Percentage of adults and babies with erythema on the face at Day 7 | At Day 7 |
| Percentage With Erythema on the Arms at Day 7 | Percentage of adults and babies with erythema on the arms at Day 7 | At Day 7 |
| Percentage With Erythema on the Legs at Day 7 | Percentage of adults and babies with erythema on the legs at Day 7 | At Day 7 |
| Percentage With Erythema on the Torso at Day 7 | Percentage of adults and babies with erythema on the torso at Day 7 | At Day 7 |
| Percentage With Erythema on the Face at Day 14 | Percentage of adults and babies with erythema on the face at Day 14 | At Day 14 |
| Percentage With Erythema on the Arms at Day 14 | Percentage of adults and babies with erythema on the arms at Day 14 | At Day 14 |
| Percentage With Erythema on the Legs at Day 14 | Percentage of adults and babies with erythema on the legs at Day 14 | At Day 14 |
| Percentage With Erythema on the Torso at Day 14 | Percentage of adults and babies with erythema on the torso at Day 14 | At Day 14 |
| Percentage With Edema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the face at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Edema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Edema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Edema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Edema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the face at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Edema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Edema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Edema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Edema on the Face at Day 1 | Percentage of adults and babies with edema on the face at Day 1 | At Day 1 |
| Percentage With Edema on the Arms at Day 1 | Percentage of adults and babies with edema on the arms at Day 1 | At Day 1 |
| Percentage With Edema on the Legs at Day 1 | Percentage of adults and babies with edema on the legs at Day 1 | At Day 1 |
| Percentage With Edema on the Torso at Day 1 | Percentage of adults and babies with edema on the torso at Day 1 | At Day 1 |
| Percentage With Edema on the Face at Day 7 | Percentage of adults and babies with edema on the face at Day 7 | At Day 7 |
| Percentage With Edema on the Arms at Day 7 | Percentage of adults and babies with edema on the arms at Day 7 | At Day 7 |
| Percentage With Edema on the Legs at Day 7 | Percentage of adults and babies with edema on the legs at Day 7 | At Day 7 |
| Percentage With Edema on the Torso at Day 7 | Percentage of adults and babies with edema on the torso at Day 7 | At Day 7 |
| Percentage With Edema on the Face at Day 14 | Percentage of adults and babies with edema on the face at Day 14 | At Day 14 |
| Percentage With Edema on the Arms at Day 14 | Percentage of adults and babies with edema on the arms at Day 14 | At Day 14 |
| Percentage With Edema on the Legs at Day 14 | Percentage of adults and babies with edema on the legs at Day 14 | At Day 14 |
| Percentage With Edema on the Torso at Day 14 | Percentage of adults and babies with edema on the torso at Day 14 | At Day 14 |
| Percentage With Scaling on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Scaling on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Scaling on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Scaling on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline before investigational product application | At baseline before investigational product application |
| Percentage With Scaling on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Scaling on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Scaling on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Scaling on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline after investigational product application | At baseline after investigational product application |
| Percentage With Scaling on the Face at Day 1 | Percentage of adults and babies with scaling on the face at Day 1 | At Day 1 |
| Percentage With Scaling on the Arms at Day 1 | Percentage of adults and babies with scaling on the arms at Day 1 | At Day 1 |
| Percentage With Scaling on the Legs at Day 1 | Percentage of adults and babies with scaling on the legs at Day 1 | At Day 1 |
| Percentage With Scaling on the Torso at Day 1 | Percentage of adults and babies with scaling on the torso at Day 1 | At Day 1 |
| Percentage With Scaling on the Face at Day 7 | Percentage of adults and babies with scaling on the face at Day 7 | At Day 7 |
| Percentage With Scaling on the Arms at Day 7 | Percentage of adults and babies with scaling on the arms at Day 7 | At Day 7 |
| Percentage With Scaling on the Legs at Day 7 | Percentage of adults and babies with scaling on the legs at Day 7 | At Day 7 |
| Percentage With Scaling on the Torso at Day 7 | Percentage of adults and babies with scaling on the torso at Day 7 | At Day 7 |
| Percentage With Scaling on the Face at Day 14 | Percentage of adults and babies with scaling on the face at Day 14 | At Day 14 |
| Percentage With Scaling on the Arms at Day 14 | Percentage of adults and babies with scaling on the arms at Day 14 | At Day 14 |
| Percentage With Scaling on the Legs at Day 14 | Percentage of adults and babies with scaling on the legs at Day 14 | At Day 14 |
| Percentage With Scaling on the Torso at Day 14 | Percentage of adults and babies with scaling on the torso at Day 14 | At Day 14 |
| Fair Lawn |
| New Jersey |
| 07410 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| months |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage With Erythema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Erythema on the Face at Day 1 | Percentage of adults and babies with erythema on the face at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Erythema on the Arms at Day 1 | Percentage of adults and babies with erythema on the arms at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Erythema on the Legs at Day 1 | Percentage of adults and babies with erythema on the legs at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Erythema on the Torso at Day 1 | Percentage of adults and babies with erythema on the torso at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Erythema on the Face at Day 7 | Percentage of adults and babies with erythema on the face at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Erythema on the Arms at Day 7 | Percentage of adults and babies with erythema on the arms at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Erythema on the Legs at Day 7 | Percentage of adults and babies with erythema on the legs at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Erythema on the Torso at Day 7 | Percentage of adults and babies with erythema on the torso at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Erythema on the Face at Day 14 | Percentage of adults and babies with erythema on the face at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Erythema on the Arms at Day 14 | Percentage of adults and babies with erythema on the arms at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Erythema on the Legs at Day 14 | Percentage of adults and babies with erythema on the legs at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Erythema on the Torso at Day 14 | Percentage of adults and babies with erythema on the torso at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Edema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the face at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Edema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Edema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Edema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Edema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the face at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Edema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Edema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Edema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Edema on the Face at Day 1 | Percentage of adults and babies with edema on the face at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Edema on the Arms at Day 1 | Percentage of adults and babies with edema on the arms at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Edema on the Legs at Day 1 | Percentage of adults and babies with edema on the legs at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Edema on the Torso at Day 1 | Percentage of adults and babies with edema on the torso at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Edema on the Face at Day 7 | Percentage of adults and babies with edema on the face at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Edema on the Arms at Day 7 | Percentage of adults and babies with edema on the arms at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Edema on the Legs at Day 7 | Percentage of adults and babies with edema on the legs at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Edema on the Torso at Day 7 | Percentage of adults and babies with edema on the torso at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Edema on the Face at Day 14 | Percentage of adults and babies with edema on the face at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Edema on the Arms at Day 14 | Percentage of adults and babies with edema on the arms at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Edema on the Legs at Day 14 | Percentage of adults and babies with edema on the legs at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Edema on the Torso at Day 14 | Percentage of adults and babies with edema on the torso at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Scaling on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline before investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline before investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline after investigational product application | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At baseline after investigational product application |
|
|
|
| Primary | Percentage With Scaling on the Face at Day 1 | Percentage of adults and babies with scaling on the face at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Scaling on the Arms at Day 1 | Percentage of adults and babies with scaling on the arms at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Scaling on the Legs at Day 1 | Percentage of adults and babies with scaling on the legs at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Scaling on the Torso at Day 1 | Percentage of adults and babies with scaling on the torso at Day 1 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 1 |
|
|
|
| Primary | Percentage With Scaling on the Face at Day 7 | Percentage of adults and babies with scaling on the face at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Scaling on the Arms at Day 7 | Percentage of adults and babies with scaling on the arms at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Scaling on the Legs at Day 7 | Percentage of adults and babies with scaling on the legs at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Scaling on the Torso at Day 7 | Percentage of adults and babies with scaling on the torso at Day 7 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 7 |
|
|
|
| Primary | Percentage With Scaling on the Face at Day 14 | Percentage of adults and babies with scaling on the face at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Scaling on the Arms at Day 14 | Percentage of adults and babies with scaling on the arms at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Scaling on the Legs at Day 14 | Percentage of adults and babies with scaling on the legs at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| Primary | Percentage With Scaling on the Torso at Day 14 | Percentage of adults and babies with scaling on the torso at Day 14 | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | Percentage of participants | At Day 14 |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Babies | Babies - 1% Colloidal Oatmeal Balm | 0 | 32 | 0 | 32 |
Principal investigators agreed not to publish the study results without prior sponsor approval.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|
| 1 (Mild) |
|
| 1.5 |
|
| 2 (Moderate) |
|
| 2.5 |
|
| 3 (Severe) |
|