Trial Outcomes & Findings for Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema (NCT NCT02357940)
NCT ID: NCT02357940
Last Updated: 2017-01-10
Results Overview
Percentage of adults and babies with erythema on the face at baseline before investigational product application
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
At baseline before investigational product application
Results posted on
2017-01-10
Participant Flow
Participant milestones
| Measure |
Adults
Adults - 1% Colloidal Oatmeal Balm
|
Babies
Babies - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
32
|
|
Overall Study
COMPLETED
|
9
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Adults
Adults - 1% Colloidal Oatmeal Balm
|
Babies
Babies - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Investigator's judgement
|
0
|
1
|
Baseline Characteristics
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
Baseline characteristics by cohort
| Measure |
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
400.0 months
STANDARD_DEVIATION 137.5 • n=5 Participants
|
22.8 months
STANDARD_DEVIATION 8.89 • n=7 Participants
|
105.6 months
STANDARD_DEVIATION 169.8 • n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
USA
|
9 participants
n=5 Participants
|
32 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the face at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
0 (None)
|
71.9 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
1 (Mild)
|
21.9 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the arms at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
0 (None)
|
65.6 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
0.5
|
9.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
1 (Mild)
|
18.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
1.5
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the legs at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
0 (None)
|
62.5 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
0.5
|
9.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
1 (Mild)
|
25.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the torso at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
0 (None)
|
84.4 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
0.5
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
1 (Mild)
|
12.5 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the face at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
0 (None)
|
75.0 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
0.5
|
6.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
1 (Mild)
|
18.8 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the arms at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
0 (None)
|
68.8 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
0.5
|
12.5 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
1 (Mild)
|
15.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the legs at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
0 (None)
|
68.8 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
0.5
|
9.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
1 (Mild)
|
18.8 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the torso at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
0 (None)
|
90.6 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
0.5
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
1 (Mild)
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the face at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Face at Day 1
0 (None)
|
87.5 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
0.5
|
3.1 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
1 (Mild)
|
9.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the arms at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Arms at Day 1
0 (None)
|
78.1 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
0.5
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
1 (Mild)
|
18.8 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the legs at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Legs at Day 1
0 (None)
|
75.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
0.5
|
15.6 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
1 (Mild)
|
9.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the torso at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Torso at Day 1
0 (None)
|
75.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
0.5
|
3.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
1 (Mild)
|
18.8 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the face at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Face at Day 7
0 (None)
|
77.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
0.5
|
6.5 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
1 (Mild)
|
16.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the arms at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Arms at Day 7
0 (None)
|
77.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
0.5
|
3.2 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
1 (Mild)
|
19.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the legs at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Legs at Day 7
0 (None)
|
83.9 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
0.5
|
3.2 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
1 (Mild)
|
12.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the torso at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Torso at Day 7
0 (None)
|
87.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
0.5
|
3.2 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
1 (Mild)
|
9.7 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the face at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Face at Day 14
0 (None)
|
76.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
0.5
|
6.7 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
1 (Mild)
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Face at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the arms at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Arms at Day 14
0 (None)
|
83.3 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
0.5
|
6.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
1 (Mild)
|
10.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Arms at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the legs at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Legs at Day 14
0 (None)
|
80.0 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
0.5
|
10.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
1 (Mild)
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
2 (Moderate)
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Legs at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with erythema on the torso at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Erythema on the Torso at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
0 (None)
|
86.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
0.5
|
3.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
1 (Mild)
|
10.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
1.5
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Erythema on the Torso at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the face at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
0 (None)
|
90.6 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
1 (Mild)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the arms at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
0 (None)
|
81.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
1 (Mild)
|
9.4 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
1.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the legs at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
0 (None)
|
81.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
0.5
|
3.1 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
2 (Moderate)
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the torso at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
0 (None)
|
84.4 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
1 (Mild)
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
1.5
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the face at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
0 (None)
|
87.5 Percentage of participants
|
77.8 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
0.5
|
9.4 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
1 (Mild)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the arms at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
0 (None)
|
87.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
0.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the legs at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
0 (None)
|
84.4 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
0.5
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the torso at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
0 (None)
|
87.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
0.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
1.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the face at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Face at Day 1
0 (None)
|
96.9 Percentage of participants
|
88.9 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
0.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
1 (Mild)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the arms at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Arms at Day 1
0 (None)
|
90.6 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
0.5
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
1 (Mild)
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the legs at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Legs at Day 1
0 (None)
|
90.6 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
0.5
|
6.3 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
1 (Mild)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the torso at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Torso at Day 1
0 (None)
|
90.6 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
0.5
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
1 (Mild)
|
3.1 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the face at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Face at Day 7
0 (None)
|
93.5 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
0.5
|
6.5 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
1 (Mild)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the arms at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Arms at Day 7
0 (None)
|
93.5 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
0.5
|
6.5 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
1 (Mild)
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the legs at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Legs at Day 7
0 (None)
|
87.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
0.5
|
6.5 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
1 (Mild)
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
1.5
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the torso at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Torso at Day 7
0 (None)
|
93.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
0.5
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
1 (Mild)
|
3.2 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
1.5
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the face at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Face at Day 14
0 (None)
|
93.3 Percentage of participants
|
77.8 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
0.5
|
0.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
1 (Mild)
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Face at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the arms at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Arms at Day 14
0 (None)
|
83.3 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
0.5
|
3.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
1 (Mild)
|
10.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
1.5
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Arms at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the legs at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Legs at Day 14
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
0 (None)
|
80.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
0.5
|
6.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
1 (Mild)
|
13.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Legs at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with edema on the torso at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Edema on the Torso at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
0 (None)
|
83.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
0.5
|
13.3 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
1 (Mild)
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Edema on the Torso at Day 14
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the face at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
0 (None)
|
81.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
0.5
|
9.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the arms at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
0 (None)
|
56.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
0.5
|
3.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
1 (Mild)
|
28.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
2 (Moderate)
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
2.5
|
0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline Before Investigational Product Application
3 (Severe)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the legs at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
0 (None)
|
34.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
1 (Mild)
|
31.3 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
1.5
|
12.5 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
2 (Moderate)
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
2.5
|
0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline Before Investigational Product Application
3 (Severe)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline before investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the torso at baseline before investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
0 (None)
|
71.9 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
0.5
|
6.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
1 (Mild)
|
12.5 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
1.5
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline Before Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the face at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
0 (None)
|
90.6 Percentage of participants
|
77.8 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
0.5
|
6.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
1 (Mild)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the arms at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
0 (None)
|
71.9 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
0.5
|
12.5 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
1 (Mild)
|
12.5 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the legs at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
0 (None)
|
56.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
0.5
|
21.9 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
1 (Mild)
|
18.8 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Baseline After Investigational Product Application
3 (Severe)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At baseline after investigational product applicationPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the torso at baseline after investigational product application
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
0 (None)
|
78.1 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
0.5
|
15.6 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
1 (Mild)
|
6.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Baseline After Investigational Product Application
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the face at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Face at Day 1
0 (None)
|
84.4 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
0.5
|
6.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
1 (Mild)
|
9.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the arms at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Arms at Day 1
0 (None)
|
75.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
0.5
|
9.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
1 (Mild)
|
9.4 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
2 (Moderate)
|
6.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the legs at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Legs at Day 1
0 (None)
|
53.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
0.5
|
18.8 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
1 (Mild)
|
18.8 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
1.5
|
3.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
2 (Moderate)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 1
3 (Severe)
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the torso at Day 1
Outcome measures
| Measure |
Babies
n=32 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Torso at Day 1
0 (None)
|
81.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
0.5
|
6.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
1 (Mild)
|
9.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
1.5
|
3.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 1
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the face at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Face at Day 7
0 (None)
|
80.6 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
0.5
|
3.2 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
1 (Mild)
|
16.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the arms at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Arms at Day 7
0 (None)
|
74.2 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
0.5
|
12.9 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
1 (Mild)
|
9.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
2 (Moderate)
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the legs at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Legs at Day 7
0 (None)
|
64.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
0.5
|
16.1 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
1 (Mild)
|
12.9 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
2 (Moderate)
|
3.2 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 7
3 (Severe)
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 7Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the torso at Day 7
Outcome measures
| Measure |
Babies
n=31 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Torso at Day 7
0 (None)
|
80.6 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
0.5
|
12.9 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
1 (Mild)
|
6.5 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 7
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the face at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Face at Day 14
0 (None)
|
83.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
0.5
|
6.7 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
1 (Mild)
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Face at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the arms at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Arms at Day 14
0 (None)
|
80.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
0.5
|
0.0 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
1 (Mild)
|
13.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
2 (Moderate)
|
6.7 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Arms at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the legs at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Legs at Day 14
0 (None)
|
70.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
0.5
|
6.7 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
1 (Mild)
|
20.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
1.5
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Legs at Day 14
3 (Severe)
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Percentage of adults and babies with scaling on the torso at Day 14
Outcome measures
| Measure |
Babies
n=30 Participants
Babies - 1% Colloidal Oatmeal Balm
|
Adults
n=9 Participants
Adults - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Percentage With Scaling on the Torso at Day 14
0 (None)
|
80.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
0.5
|
13.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
1 (Mild)
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
1.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
2 (Moderate)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
2.5
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage With Scaling on the Torso at Day 14
3 (Severe)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Adults
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Babies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adults
n=9 participants at risk
Adults - 1% Colloidal Oatmeal Balm
|
Babies
n=32 participants at risk
Babies - 1% Colloidal Oatmeal Balm
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.1%
1/9 • 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.
|
0.00%
0/32 • 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.
|
Additional Information
Amisha Parikh-Das, PhD/Study Director
Johnson & Johnson Consumer Inc.
Phone: 973-255-8701 USA EST
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER