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Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02357940
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : November 15, 2016
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis (AD)
Intervention Drug: Experimental Product
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adults Babies
Hide Arm/Group Description Adults - 1% Colloidal Oatmeal Balm Babies - 1% Colloidal Oatmeal Balm
Period Title: Overall Study
Started 9 32
Completed 9 30
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Investigator's judgement             0             1
Arm/Group Title Adults Babies Total
Hide Arm/Group Description Adults - 1% Colloidal Oatmeal Balm Babies - 1% Colloidal Oatmeal Balm Total of all reporting groups
Overall Number of Baseline Participants 9 32 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 9 participants 32 participants 41 participants
400.0  (137.5) 22.8  (8.89) 105.6  (169.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 32 participants 41 participants
Female
6
  66.7%
13
  40.6%
19
  46.3%
Male
3
  33.3%
19
  59.4%
22
  53.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 9 participants 32 participants 41 participants
9 32 41
1.Primary Outcome
Title Percentage With Erythema on the Face at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the face at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 71.9
0.5 55.6 6.3
1 (Mild) 11.1 21.9
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
2.Primary Outcome
Title Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the arms at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 65.6
0.5 22.2 9.4
1 (Mild) 0.0 18.8
1.5 0.0 6.3
2 (Moderate) 22.2 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
3.Primary Outcome
Title Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the legs at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 62.5
0.5 33.3 9.4
1 (Mild) 11.1 25.0
1.5 11.1 0.0
2 (Moderate) 11.1 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
4.Primary Outcome
Title Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the torso at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 84.4
0.5 22.2 0.0
1 (Mild) 22.2 12.5
1.5 0.0 3.1
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
5.Primary Outcome
Title Percentage With Erythema on the Face at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the face at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 75.0
0.5 33.3 6.3
1 (Mild) 11.1 18.8
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
6.Primary Outcome
Title Percentage With Erythema on the Arms at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the arms at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 68.8
0.5 22.2 12.5
1 (Mild) 0.0 15.6
1.5 0.0 3.1
2 (Moderate) 22.2 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
7.Primary Outcome
Title Percentage With Erythema on the Legs at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the legs at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 68.8
0.5 22.2 9.4
1 (Mild) 11.1 18.8
1.5 11.1 3.1
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
8.Primary Outcome
Title Percentage With Erythema on the Torso at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with erythema on the torso at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 90.6
0.5 22.2 0.0
1 (Mild) 22.2 3.1
1.5 0.0 3.1
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
9.Primary Outcome
Title Percentage With Erythema on the Face at Day 1
Hide Description Percentage of adults and babies with erythema on the face at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 87.5
0.5 44.4 3.1
1 (Mild) 0.0 9.4
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
10.Primary Outcome
Title Percentage With Erythema on the Arms at Day 1
Hide Description Percentage of adults and babies with erythema on the arms at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 78.1
0.5 22.2 3.1
1 (Mild) 11.1 18.8
1.5 11.1 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
11.Primary Outcome
Title Percentage With Erythema on the Legs at Day 1
Hide Description Percentage of adults and babies with erythema on the legs at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 75.0
0.5 22.2 15.6
1 (Mild) 22.2 9.4
1.5 11.1 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
12.Primary Outcome
Title Percentage With Erythema on the Torso at Day 1
Hide Description Percentage of adults and babies with erythema on the torso at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 75.0
0.5 33.3 3.1
1 (Mild) 22.2 18.8
1.5 0.0 3.1
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
13.Primary Outcome
Title Percentage With Erythema on the Face at Day 7
Hide Description Percentage of adults and babies with erythema on the face at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 22.2 77.4
0.5 55.6 6.5
1 (Mild) 22.2 16.1
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
14.Primary Outcome
Title Percentage With Erythema on the Arms at Day 7
Hide Description Percentage of adults and babies with erythema on the arms at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 77.4
0.5 33.3 3.2
1 (Mild) 22.2 19.4
1.5 0.0 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
15.Primary Outcome
Title Percentage With Erythema on the Legs at Day 7
Hide Description Percentage of adults and babies with erythema on the legs at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 83.9
0.5 55.6 3.2
1 (Mild) 0.0 12.9
1.5 0.0 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
16.Primary Outcome
Title Percentage With Erythema on the Torso at Day 7
Hide Description Percentage of adults and babies with erythema on the torso at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 87.1
0.5 44.4 3.2
1 (Mild) 22.2 9.7
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
17.Primary Outcome
Title Percentage With Erythema on the Face at Day 14
Hide Description Percentage of adults and babies with erythema on the face at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 76.7
0.5 55.6 6.7
1 (Mild) 0.0 16.7
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
18.Primary Outcome
Title Percentage With Erythema on the Arms at Day 14
Hide Description Percentage of adults and babies with erythema on the arms at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 83.3
0.5 44.4 6.7
1 (Mild) 11.1 10.0
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
19.Primary Outcome
Title Percentage With Erythema on the Legs at Day 14
Hide Description Percentage of adults and babies with erythema on the legs at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 80.0
0.5 33.3 10.0
1 (Mild) 0.0 6.7
1.5 11.1 0.0
2 (Moderate) 0.0 3.3
2.5 0.0 0.0
3 (Severe) 0.0 0.0
20.Primary Outcome
Title Percentage With Erythema on the Torso at Day 14
Hide Description Percentage of adults and babies with erythema on the torso at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 86.7
0.5 33.3 3.3
1 (Mild) 11.1 10.0
1.5 0 0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
21.Primary Outcome
Title Percentage With Edema on the Face at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with edema on the face at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 90.6
0.5 33.3 6.3
1 (Mild) 0.0 3.1
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
22.Primary Outcome
Title Percentage With Edema on the Arms at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with edema on the arms at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 81.3
0.5 0.0 6.3
1 (Mild) 11.1 9.4
1.5 11.1 3.1
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
23.Primary Outcome
Title Percentage With Edema on the Legs at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with edema on the legs at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 22.2 81.3
0.5 44.4 3.1
1 (Mild) 11.1 6.3
1.5 0.0 3.1
2 (Moderate) 22.2 6.3
2.5 0.0 0.0
3 (Severe) 0.0 0.0
24.Primary Outcome
Title Percentage With Edema on the Torso at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with edema on the torso at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 84.4
0.5 22.2 6.3
1 (Mild) 22.2 3.1
1.5 11.1 6.3
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
25.Primary Outcome
Title Percentage With Edema on the Face at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with edema on the face at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 77.8 87.5
0.5 22.2 9.4
1 (Mild) 0.0 3.1
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
26.Primary Outcome
Title Percentage With Edema on the Arms at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with edema on the arms at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 87.5
0.5 11.1 3.1
1 (Mild) 0.0 6.3
1.5 0.0 3.1
2 (Moderate) 22.2 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
27.Primary Outcome
Title Percentage With Edema on the Legs at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with edema on the legs at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 84.4
0.5 22.2 3.1
1 (Mild) 11.1 6.3
1.5 11.1 3.1
2 (Moderate) 11.1 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
28.Primary Outcome
Title Percentage With Edema on the Torso at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with edema on the torso at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 87.5
0.5 0.0 3.1
1 (Mild) 22.2 6.3
1.5 11.1 3.1
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
29.Primary Outcome
Title Percentage With Edema on the Face at Day 1
Hide Description Percentage of adults and babies with edema on the face at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 88.9 96.9
0.5 11.1 0.0
1 (Mild) 0.0 3.1
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
30.Primary Outcome
Title Percentage With Edema on the Arms at Day 1
Hide Description Percentage of adults and babies with edema on the arms at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 90.6
0.5 11.1 6.3
1 (Mild) 22.2 3.1
1.5 0.0 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
31.Primary Outcome
Title Percentage With Edema on the Legs at Day 1
Hide Description Percentage of adults and babies with edema on the legs at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 90.6
0.5 44.4 6.3
1 (Mild) 11.1 0.0
1.5 11.1 0.0
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
32.Primary Outcome
Title Percentage With Edema on the Torso at Day 1
Hide Description Percentage of adults and babies with edema on the torso at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 90.6
0.5 0.0 6.3
1 (Mild) 22.2 3.1
1.5 11.1 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
33.Primary Outcome
Title Percentage With Edema on the Face at Day 7
Hide Description Percentage of adults and babies with edema on the face at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 93.5
0.5 33.3 6.5
1 (Mild) 11.1 0.0
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
34.Primary Outcome
Title Percentage With Edema on the Arms at Day 7
Hide Description Percentage of adults and babies with edema on the arms at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 93.5
0.5 22.2 6.5
1 (Mild) 22.2 0.0
1.5 0.0 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
35.Primary Outcome
Title Percentage With Edema on the Legs at Day 7
Hide Description Percentage of adults and babies with edema on the legs at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 87.1
0.5 55.6 6.5
1 (Mild) 0.0 3.2
1.5 0.0 3.2
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
36.Primary Outcome
Title Percentage With Edema on the Torso at Day 7
Hide Description Percentage of adults and babies with edema on the torso at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 93.5
0.5 0.0 3.2
1 (Mild) 11.1 3.2
1.5 22.2 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
37.Primary Outcome
Title Percentage With Edema on the Face at Day 14
Hide Description Percentage of adults and babies with edema on the face at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 77.8 93.3
0.5 22.2 0.0
1 (Mild) 0.0 6.7
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
38.Primary Outcome
Title Percentage With Edema on the Arms at Day 14
Hide Description Percentage of adults and babies with edema on the arms at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 83.3
0.5 22.2 3.3
1 (Mild) 22.2 10.0
1.5 0.0 3.3
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
39.Primary Outcome
Title Percentage With Edema on the Legs at Day 14
Hide Description Percentage of adults and babies with edema on the legs at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 80.0
0.5 44.4 6.7
1 (Mild) 0.0 13.3
1.5 11.1 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
40.Primary Outcome
Title Percentage With Edema on the Torso at Day 14
Hide Description Percentage of adults and babies with edema on the torso at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 83.3
0.5 44.4 13.3
1 (Mild) 0.0 3.3
1.5 11.1 0.0
2 (Moderate) 11.1 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
41.Primary Outcome
Title Percentage With Scaling on the Face at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the face at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 81.3
0.5 33.3 9.4
1 (Mild) 0.0 6.3
1.5 0.0 0.0
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
42.Primary Outcome
Title Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the arms at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 11.1 56.3
0.5 33.3 3.1
1 (Mild) 33.3 28.1
1.5 0.0 3.1
2 (Moderate) 22.2 6.3
2.5 0.0 0
3 (Severe) 0.0 3.1
43.Primary Outcome
Title Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the legs at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 0.0 34.4
0.5 22.2 6.3
1 (Mild) 44.4 31.3
1.5 22.2 12.5
2 (Moderate) 0.0 12.5
2.5 11.1 0
3 (Severe) 0.0 3.1
44.Primary Outcome
Title Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the torso at baseline before investigational product application
Time Frame At baseline before investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 22.2 71.9
0.5 66.7 6.3
1 (Mild) 11.1 12.5
1.5 0.0 6.3
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
45.Primary Outcome
Title Percentage With Scaling on the Face at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the face at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 77.8 90.6
0.5 22.2 6.3
1 (Mild) 0.0 0.0
1.5 0.0 0.0
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
46.Primary Outcome
Title Percentage With Scaling on the Arms at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the arms at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 71.9
0.5 44.4 12.5
1 (Mild) 22.2 12.5
1.5 0.0 0.0
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 0.0
47.Primary Outcome
Title Percentage With Scaling on the Legs at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the legs at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 22.2 56.3
0.5 66.7 21.9
1 (Mild) 11.1 18.8
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 3.1
48.Primary Outcome
Title Percentage With Scaling on the Torso at Baseline After Investigational Product Application
Hide Description Percentage of adults and babies with scaling on the torso at baseline after investigational product application
Time Frame At baseline after investigational product application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 78.1
0.5 44.4 15.6
1 (Mild) 0.0 6.3
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
49.Primary Outcome
Title Percentage With Scaling on the Face at Day 1
Hide Description Percentage of adults and babies with scaling on the face at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 84.4
0.5 33.3 6.3
1 (Mild) 0.0 9.4
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
50.Primary Outcome
Title Percentage With Scaling on the Arms at Day 1
Hide Description Percentage of adults and babies with scaling on the arms at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 75.0
0.5 33.3 9.4
1 (Mild) 11.1 9.4
1.5 0.0 0.0
2 (Moderate) 11.1 6.3
2.5 0.0 0.0
3 (Severe) 0.0 0.0
51.Primary Outcome
Title Percentage With Scaling on the Legs at Day 1
Hide Description Percentage of adults and babies with scaling on the legs at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 11.1 53.1
0.5 66.7 18.8
1 (Mild) 11.1 18.8
1.5 11.1 3.1
2 (Moderate) 0.0 3.1
2.5 0.0 0.0
3 (Severe) 0.0 3.1
52.Primary Outcome
Title Percentage With Scaling on the Torso at Day 1
Hide Description Percentage of adults and babies with scaling on the torso at Day 1
Time Frame At Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 32
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 81.3
0.5 66.7 6.3
1 (Mild) 0.0 9.4
1.5 0.0 3.1
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
53.Primary Outcome
Title Percentage With Scaling on the Face at Day 7
Hide Description Percentage of adults and babies with scaling on the face at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 55.6 80.6
0.5 44.4 3.2
1 (Mild) 0.0 16.1
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
54.Primary Outcome
Title Percentage With Scaling on the Arms at Day 7
Hide Description Percentage of adults and babies with scaling on the arms at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 74.2
0.5 55.6 12.9
1 (Mild) 0.0 9.7
1.5 0.0 0.0
2 (Moderate) 0.0 3.2
2.5 0.0 0.0
3 (Severe) 0.0 0.0
55.Primary Outcome
Title Percentage With Scaling on the Legs at Day 7
Hide Description Percentage of adults and babies with scaling on the legs at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 0.0 64.5
0.5 44.4 16.1
1 (Mild) 44.4 12.9
1.5 0.0 0.0
2 (Moderate) 11.1 3.2
2.5 0.0 0.0
3 (Severe) 0.0 3.2
56.Primary Outcome
Title Percentage With Scaling on the Torso at Day 7
Hide Description Percentage of adults and babies with scaling on the torso at Day 7
Time Frame At Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 44.4 80.6
0.5 44.4 12.9
1 (Mild) 11.1 6.5
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
57.Primary Outcome
Title Percentage With Scaling on the Face at Day 14
Hide Description Percentage of adults and babies with scaling on the face at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 66.7 83.3
0.5 33.3 6.7
1 (Mild) 0.0 10.0
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
58.Primary Outcome
Title Percentage With Scaling on the Arms at Day 14
Hide Description Percentage of adults and babies with scaling on the arms at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 80.0
0.5 44.4 0.0
1 (Mild) 11.1 13.3
1.5 0.0 0.0
2 (Moderate) 11.1 6.7
2.5 0.0 0.0
3 (Severe) 0.0 0.0
59.Primary Outcome
Title Percentage With Scaling on the Legs at Day 14
Hide Description Percentage of adults and babies with scaling on the legs at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 22.2 70.0
0.5 44.4 6.7
1 (Mild) 22.2 20.0
1.5 11.1 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 3.3
60.Primary Outcome
Title Percentage With Scaling on the Torso at Day 14
Hide Description Percentage of adults and babies with scaling on the torso at Day 14
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Adults Babies
Hide Arm/Group Description:
Adults - 1% Colloidal Oatmeal Balm
Babies - 1% Colloidal Oatmeal Balm
Overall Number of Participants Analyzed 9 30
Measure Type: Number
Unit of Measure: Percentage of participants
0 (None) 33.3 80.0
0.5 66.7 13.3
1 (Mild) 0.0 6.7
1.5 0.0 0.0
2 (Moderate) 0.0 0.0
2.5 0.0 0.0
3 (Severe) 0.0 0.0
Time Frame Day 14 ± 2 days, +30 days for serious adverse events.
Adverse Event Reporting Description 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.
 
Arm/Group Title Adults Babies
Hide Arm/Group Description Adults - 1% Colloidal Oatmeal Balm Babies - 1% Colloidal Oatmeal Balm
All-Cause Mortality
Adults Babies
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adults Babies
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adults Babies
Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   0/32 (0.00%) 
Nervous system disorders     
Headache  1  1/9 (11.11%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigators agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Name/Title: Amisha Parikh-Das, PhD/Study Director
Organization: Johnson & Johnson Consumer Inc.
Phone: 973-255-8701 USA EST
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT02357940     History of Changes
Other Study ID Numbers: CO-140908134135-SBCT
First Submitted: February 3, 2015
First Posted: February 6, 2015
Results First Submitted: July 26, 2016
Results First Posted: November 15, 2016
Last Update Posted: January 10, 2017