Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, skin care
Brief summary
The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
Detailed description
Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group using Johnson & Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. The procedures are as follows: * Transepidermal loss (TEWL - measures the water loss from the skin) * Skin electrical capacitance (measures how much water stays in the top layer of skin) * Skin pH (measures level of pH) * Skin microbiome analysis (skin swabs to check genetic code of skin bacteria) * Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top layer of skin) Both groups will be reminded to follow the instructions about general good skin care of infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. Defects in the gene called filaggrin have been shown to increase the risk of developing eczema. The samples will be identified by a code to protect your infant's identity. The saliva samples will be stored only for this study, and then the sample will be destroyed.
Interventions
OTHERCetaphil Restoraderm
Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
OTHERStandard of Care
Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.
Sponsors
Galderma R&D
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study. * Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.
Exclusion criteria
* Preterm birth defined as birth prior to 37 weeks gestation * Major congenital anomaly * Hydrops fetalis * Significant dermatitis at birth not including seborrheic dermatitis on the scalp (cradle cap) * Any immunodeficiency disorder * Any severe genetic skin disorder * Any other serious condition that would make the use of emollients inadvisable * Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months | 12 months | Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age at Onset of Eczema | Baseline through Month 24 Follow-up | Age of subject at onset of eczema |
| Filaggrin Mutation Status | 6 month visit | Filaggrin mutation status result |
| Percentage of High Emollient Use | 2, 6, 12, 18, and 24 months | Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week. |
| Skin Hydration (Skin Electrical Capacitance) | 2 month, 6 month, and 12 month visits | Determination of stratum corneum hydration from the dorsal forearm |
| Skin pH | 2 month, 6 month, and 12 month visits | Skin pH, as measured using a pH probe |
| Transepidermal Water Loss (TEWL) | 2 month, 6 month, and 12 month visits | Transepidermal water loss (TEWL) to measure skin barrier function |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cetaphil Restoraderm Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. | 54 |
| Standard of Care Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.
Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. | 46 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 12 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Cetaphil Restoraderm | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 54 Participants | 46 Participants | 100 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 54 participants | 46 participants | 100 participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Male | 30 Participants | 21 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 46 |
| other Total, other adverse events | 30 / 54 | 21 / 46 |
| serious Total, serious adverse events | 2 / 54 | 0 / 46 |
Outcome results
Primary
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months
Time frame: 12 months
Population: Around 28% of subjects enrolled were lost to follow-up by 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetaphil Restoraderm | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months | 13.2 Percentage of participants |
| Standard of Care | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months | 25 Percentage of participants |
Secondary
Age at Onset of Eczema
Age of subject at onset of eczema
Time frame: Baseline through Month 24 Follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cetaphil Restoraderm | Age at Onset of Eczema | 4 months |
| Standard of Care | Age at Onset of Eczema | 6 months |
Secondary
Filaggrin Mutation Status
Filaggrin mutation status result
Time frame: 6 month visit
Population: Number of participants analyzed captures only those participants that completed 6 month filaggrin testing. Not all participants noted in the overall participant flow were able to complete filaggrin testing either due to study status (i.e., lost to follow up, withdrawn) or missed visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cetaphil Restoraderm | Filaggrin Mutation Status | Positive for Filaggrin Mutation | 3 Participants |
| Cetaphil Restoraderm | Filaggrin Mutation Status | Negative for Filaggrin Mutation | 22 Participants |
| Standard of Care | Filaggrin Mutation Status | Positive for Filaggrin Mutation | 2 Participants |
| Standard of Care | Filaggrin Mutation Status | Negative for Filaggrin Mutation | 29 Participants |
Secondary
Percentage of High Emollient Use
Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week.
Time frame: 2, 6, 12, 18, and 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cetaphil Restoraderm | Percentage of High Emollient Use | Percentage of high emollient use at 6 months | 72.4 percentage of participants |
| Cetaphil Restoraderm | Percentage of High Emollient Use | Percentage of high emollient use at 18 months | 52.2 percentage of participants |
| Cetaphil Restoraderm | Percentage of High Emollient Use | Percentage of high emollient use at 12 months | 66.7 percentage of participants |
| Cetaphil Restoraderm | Percentage of High Emollient Use | Percentage of high emollient use at 24 months | 40.0 percentage of participants |
| Cetaphil Restoraderm | Percentage of High Emollient Use | Percentage of high emollient use at 2 months | 87 percentage of participants |
| Standard of Care | Percentage of High Emollient Use | Percentage of high emollient use at 24 months | 33.3 percentage of participants |
| Standard of Care | Percentage of High Emollient Use | Percentage of high emollient use at 2 months | 45.2 percentage of participants |
| Standard of Care | Percentage of High Emollient Use | Percentage of high emollient use at 6 months | 45.8 percentage of participants |
| Standard of Care | Percentage of High Emollient Use | Percentage of high emollient use at 12 months | 45.5 percentage of participants |
| Standard of Care | Percentage of High Emollient Use | Percentage of high emollient use at 18 months | 53.3 percentage of participants |
Secondary
Skin Hydration (Skin Electrical Capacitance)
Determination of stratum corneum hydration from the dorsal forearm
Time frame: 2 month, 6 month, and 12 month visits
Population: Number of participants analyzed captures only those participants that completed skin hydration testing at all time points. Not all participants noted in the overall participant flow were able to complete skin hydration testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cetaphil Restoraderm | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 2 months | 55.2 farads | Standard Deviation 14 |
| Cetaphil Restoraderm | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 6 months | 51.8 farads | Standard Deviation 9.8 |
| Cetaphil Restoraderm | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 12 months | 49.4 farads | Standard Deviation 12.7 |
| Standard of Care | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 2 months | 53.9 farads | Standard Deviation 8.2 |
| Standard of Care | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 6 months | 52.1 farads | Standard Deviation 6.1 |
| Standard of Care | Skin Hydration (Skin Electrical Capacitance) | Average capacitance at 12 months | 53.7 farads | Standard Deviation 14 |
Secondary
Skin pH
Skin pH, as measured using a pH probe
Time frame: 2 month, 6 month, and 12 month visits
Population: Number of participants analyzed captures only those participants that completed Skin pH testing at all time points. Not all participants noted in the overall participant flow were able to complete Skin pH testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cetaphil Restoraderm | Skin pH | Average pH at 2 months | 5.5 pH | Standard Deviation 0.4 |
| Cetaphil Restoraderm | Skin pH | Average pH at 6 months | 5.3 pH | Standard Deviation 0.6 |
| Cetaphil Restoraderm | Skin pH | Average pH at 12 months | 5.4 pH | Standard Deviation 0.7 |
| Standard of Care | Skin pH | Average pH at 2 months | 5.2 pH | Standard Deviation 0.4 |
| Standard of Care | Skin pH | Average pH at 6 months | 5.4 pH | Standard Deviation 0.5 |
| Standard of Care | Skin pH | Average pH at 12 months | 5.4 pH | Standard Deviation 0.5 |
Secondary
Transepidermal Water Loss (TEWL)
Transepidermal water loss (TEWL) to measure skin barrier function
Time frame: 2 month, 6 month, and 12 month visits
Population: Number of participants analyzed captures only those participants that completed TEWL testing at all time points. Not all participants noted in the overall participant flow were able to complete TEWL testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cetaphil Restoraderm | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 2 months | 16.3 (g/[m2hr]) | Standard Deviation 7.1 |
| Cetaphil Restoraderm | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 6 months | 15.9 (g/[m2hr]) | Standard Deviation 5.6 |
| Cetaphil Restoraderm | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 12 months | 13.9 (g/[m2hr]) | Standard Deviation 2.3 |
| Standard of Care | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 2 months | 18.3 (g/[m2hr]) | Standard Deviation 8.6 |
| Standard of Care | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 6 months | 16.1 (g/[m2hr]) | Standard Deviation 6.2 |
| Standard of Care | Transepidermal Water Loss (TEWL) | Average TEWL (g/[m2hr]) at 12 months | 16.7 (g/[m2hr]) | Standard Deviation 5.6 |
Post Hoc
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months
Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months
Time frame: 24 Months
Population: Number of participants analyzed captures only those participants still on study at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetaphil Restoraderm | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months | 19.4 percentage of participants |
| Standard of Care | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months | 31.0 percentage of participants |