Atopic Dermatitis
Conditions
Brief summary
The purpose of this study is to evaluate the effect of Cetaphil® Restoraderm® skin restoring moisturizer in reducing the signs and symptoms of very dry atopic skin in young children. Subjects with atopic dermatitis (AD) in remission phase will be randomized to receive either Cetaphil® Restoraderm® skin restoring body wash only, or the same body wash in association with Cetaphil® Restoraderm® skin restoring moisturizer.
Detailed description
Two groups randomized in a ratio of \[1:1\] for a 12-week period Five study evaluation were planned: at Baseline, week 2, Week 4, Week8 and Week12
Interventions
OTHERCetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash
OTHERCetaphil® Restoraderm® body wash
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject, aged 2 to 12 years inclusive * Controlled mild to moderate atopic dermatitis with a Investigator Global Assessment score at 0 or 1, within one week after successful treatment with topical corticosteroid.
Exclusion criteria
* Subject presenting bacterial, viral, fungal or parasite skin infection * Subject with ulcerated lesions, acne or rosacea * Immunosuppression * Subject with a wash-out period from baseline for topical treatment less than 8 days for Calcineurin inhibitor * Subject with a wash-out period from baseline for topical treatment more than 8 days for corticosteroid * Subject with a wash-out period from baseline for systemic treatment less than 8 days for anti-histamines, less than 4 weeks for immunomodulators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse (Quantile 25%) | The duration between Baseline and the first AD relapse occurred (up to 89 days) | Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached. |
Countries
China, Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moisturizer + Body Wash Cetaphil® Restoraderm® moisturizer (2/day) + Cetaphil® Restoraderm® Skin body wash (1/day)
Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash | 60 |
| Body Wash Cetaphil® Restoraderm® body wash (1/day)
Cetaphil® Restoraderm® body wash | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Sponsor decision to withdraw subject | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Moisturizer + Body Wash | Total | Body Wash |
|---|---|---|---|
| Age, Continuous | 5.9 years STANDARD_DEVIATION 2.9 | 5.9 years STANDARD_DEVIATION 2.9 | 5.9 years STANDARD_DEVIATION 2.9 |
| Atopic Dermatitis (AD) duration | 2.9 years STANDARD_DEVIATION 3.4 | 2.8 years STANDARD_DEVIATION 3.1 | 2.7 years STANDARD_DEVIATION 2.9 |
| Duration of the last acute phase | 27.9 days STANDARD_DEVIATION 40.8 | 27.4 days STANDARD_DEVIATION 47.3 | 27.0 days STANDARD_DEVIATION 53.5 |
| Eczema Area and Severity Index (EASI) Erythema | 0.13 scores on a scale STANDARD_DEVIATION 0.21 | 0.12 scores on a scale STANDARD_DEVIATION 0.19 | 0.10 scores on a scale STANDARD_DEVIATION 0.17 |
| Eczema Area and Severity Index (EASI) Excoriation | 0.07 scores on a scale STANDARD_DEVIATION 0.15 | 0.08 scores on a scale STANDARD_DEVIATION 0.18 | 0.10 scores on a scale STANDARD_DEVIATION 0.21 |
| Eczema Area and Severity Index (EASI) infiltration / Papulation | 0.09 scores on a scale STANDARD_DEVIATION 0.19 | 0.09 scores on a scale STANDARD_DEVIATION 0.18 | 0.08 scores on a scale STANDARD_DEVIATION 0.17 |
| Eczema Area and Severity Index (EASI) Lichenification | 0.04 scores on a scale STANDARD_DEVIATION 0.1 | 0.03 scores on a scale STANDARD_DEVIATION 0.09 | 0.02 scores on a scale STANDARD_DEVIATION 0.07 |
| Investigator's Global Assessment (IGA) 0-Clear | 20 Participants | 42 Participants | 22 Participants |
| Investigator's Global Assessment (IGA) 1-Almost clear | 40 Participants | 78 Participants | 38 Participants |
| Number of AD acute phase in the last 12 months | 4.1 episodes STANDARD_DEVIATION 3.7 | 3.9 episodes STANDARD_DEVIATION 3.5 | 3.7 episodes STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 118 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Severity of the last AD acute phase Mild | 44 Participants | 85 Participants | 41 Participants |
| Severity of the last AD acute phase Moderate | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Female | 37 Participants | 70 Participants | 33 Participants |
| Sex: Female, Male Male | 23 Participants | 50 Participants | 27 Participants |
| Skin phototype II | 0 participants | 1 participants | 1 participants |
| Skin phototype III | 17 participants | 37 participants | 20 participants |
| Skin phototype IV | 43 participants | 82 participants | 39 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 14 / 60 | 17 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Time to Relapse (Quantile 25%)
Time to relapse corresponds to date of relapse - date of baseline. Quantile 25% replaced the median time to relapse that was not reached.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moisturizer + Body Wash | Time to Relapse (Quantile 25%) | 48 Days |
| Body Wash | Time to Relapse (Quantile 25%) | 15 Days |