Trial Outcomes & Findings for Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis (NCT NCT02589392)
NCT ID: NCT02589392
Last Updated: 2024-02-26
Results Overview
Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
The duration between Baseline and the first AD relapse occurred (up to 89 days)
Results posted on
2024-02-26
Participant Flow
Participant milestones
| Measure |
Moisturizer + Body Wash
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
|
Body Wash
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Moisturizer + Body Wash
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
|
Body Wash
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Sponsor decision to withdraw subject
|
1
|
0
|
Baseline Characteristics
Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Moisturizer + Body Wash
n=60 Participants
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
|
Body Wash
n=60 Participants
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Severity of the last AD acute phase
Moderate
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Continuous
|
5.9 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
5.9 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
5.9 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Skin phototype
II
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Skin phototype
III
|
17 participants
n=99 Participants
|
20 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Skin phototype
IV
|
43 participants
n=99 Participants
|
39 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Atopic Dermatitis (AD) duration
|
2.9 years
STANDARD_DEVIATION 3.4 • n=99 Participants
|
2.7 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
2.8 years
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Number of AD acute phase in the last 12 months
|
4.1 episodes
STANDARD_DEVIATION 3.7 • n=99 Participants
|
3.7 episodes
STANDARD_DEVIATION 3.3 • n=107 Participants
|
3.9 episodes
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Duration of the last acute phase
|
27.9 days
STANDARD_DEVIATION 40.8 • n=99 Participants
|
27.0 days
STANDARD_DEVIATION 53.5 • n=107 Participants
|
27.4 days
STANDARD_DEVIATION 47.3 • n=206 Participants
|
|
Severity of the last AD acute phase
Mild
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Investigator's Global Assessment (IGA)
0-Clear
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Investigator's Global Assessment (IGA)
1-Almost clear
|
40 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Eczema Area and Severity Index (EASI)
Erythema
|
0.13 scores on a scale
STANDARD_DEVIATION 0.21 • n=99 Participants
|
0.10 scores on a scale
STANDARD_DEVIATION 0.17 • n=107 Participants
|
0.12 scores on a scale
STANDARD_DEVIATION 0.19 • n=206 Participants
|
|
Eczema Area and Severity Index (EASI)
infiltration / Papulation
|
0.09 scores on a scale
STANDARD_DEVIATION 0.19 • n=99 Participants
|
0.08 scores on a scale
STANDARD_DEVIATION 0.17 • n=107 Participants
|
0.09 scores on a scale
STANDARD_DEVIATION 0.18 • n=206 Participants
|
|
Eczema Area and Severity Index (EASI)
Excoriation
|
0.07 scores on a scale
STANDARD_DEVIATION 0.15 • n=99 Participants
|
0.10 scores on a scale
STANDARD_DEVIATION 0.21 • n=107 Participants
|
0.08 scores on a scale
STANDARD_DEVIATION 0.18 • n=206 Participants
|
|
Eczema Area and Severity Index (EASI)
Lichenification
|
0.04 scores on a scale
STANDARD_DEVIATION 0.10 • n=99 Participants
|
0.02 scores on a scale
STANDARD_DEVIATION 0.07 • n=107 Participants
|
0.03 scores on a scale
STANDARD_DEVIATION 0.09 • n=206 Participants
|
PRIMARY outcome
Timeframe: The duration between Baseline and the first AD relapse occurred (up to 89 days)Population: Analysis was performed on intent-to-treat efficacy (ITT) population that included all participants who were enrolled and randomized.
Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.
Outcome measures
| Measure |
Moisturizer + Body Wash
n=60 Participants
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
|
Body Wash
n=60 Participants
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
|---|---|---|
|
Time to Relapse (Quantile 25%)
|
48 Days
Interval 11.0 to 86.0
|
15 Days
Interval 8.0 to 27.0
|
Adverse Events
Moisturizer + Body Wash
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Body Wash
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moisturizer + Body Wash
n=60 participants at risk
Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
|
Body Wash
n=60 participants at risk
Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash
|
|---|---|---|
|
General disorders
PYREXIA
|
6.7%
4/60 • Number of events 5 • 8 months
Analysis was based on safety population that included all treated population.
|
5.0%
3/60 • Number of events 3 • 8 months
Analysis was based on safety population that included all treated population.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
3/60 • Number of events 3 • 8 months
Analysis was based on safety population that included all treated population.
|
5.0%
3/60 • Number of events 3 • 8 months
Analysis was based on safety population that included all treated population.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.0%
3/60 • Number of events 3 • 8 months
Analysis was based on safety population that included all treated population.
|
10.0%
6/60 • Number of events 8 • 8 months
Analysis was based on safety population that included all treated population.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.3%
2/60 • Number of events 2 • 8 months
Analysis was based on safety population that included all treated population.
|
3.3%
2/60 • Number of events 2 • 8 months
Analysis was based on safety population that included all treated population.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
3.3%
2/60 • Number of events 2 • 8 months
Analysis was based on safety population that included all treated population.
|
5.0%
3/60 • Number of events 3 • 8 months
Analysis was based on safety population that included all treated population.
|
|
Infections and infestations
VIRAL INFECTION
|
1.7%
1/60 • Number of events 1 • 8 months
Analysis was based on safety population that included all treated population.
|
3.3%
2/60 • Number of events 2 • 8 months
Analysis was based on safety population that included all treated population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement covered by contract.
- Publication restrictions are in place
Restriction type: OTHER