Trial Outcomes & Findings for Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants (NCT NCT01375205)

NCT ID: NCT01375205

Last Updated: 2020-02-12

Results Overview

Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-02-12

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	54	46
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	21	13

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	15	12
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Baseline characteristics by cohort

Measure	Cetaphil Restoraderm n=54 Participants 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.	Standard of Care n=46 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	54 Participants n=5 Participants	46 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	46 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Around 28% of subjects enrolled were lost to follow-up by 12 months

Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months

Outcome measures

Measure	Cetaphil Restoraderm n=38 Participants 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.	Standard of Care n=32 Participants 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.
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months	13.2 Percentage of participants	25 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cetaphil Restoraderm n=54 Participants 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.	Standard of Care n=46 Participants 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.
Percentage of High Emollient Use Percentage of high emollient use at 2 months	87 percentage of participants	45.2 percentage of participants
Percentage of High Emollient Use Percentage of high emollient use at 6 months	72.4 percentage of participants	45.8 percentage of participants
Percentage of High Emollient Use Percentage of high emollient use at 12 months	66.7 percentage of participants	45.5 percentage of participants
Percentage of High Emollient Use Percentage of high emollient use at 18 months	52.2 percentage of participants	53.3 percentage of participants
Percentage of High Emollient Use Percentage of high emollient use at 24 months	40.0 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline through Month 24 Follow-up

Age of subject at onset of eczema

Outcome measures

Measure	Cetaphil Restoraderm n=54 Participants 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.	Standard of Care n=46 Participants 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.
Age at Onset of Eczema	4 months Interval 0.0 to 24.0	6 months Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: 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.

Filaggrin mutation status result

Outcome measures

Measure	Cetaphil Restoraderm n=25 Participants 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.	Standard of Care n=31 Participants 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.
Filaggrin Mutation Status Positive for Filaggrin Mutation	3 Participants	2 Participants
Filaggrin Mutation Status Negative for Filaggrin Mutation	22 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Transepidermal water loss (TEWL) to measure skin barrier function

Outcome measures

Measure	Cetaphil Restoraderm n=32 Participants 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.	Standard of Care n=24 Participants 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.
Transepidermal Water Loss (TEWL) Average TEWL (g/[m2hr]) at 2 months	16.3 (g/[m2hr]) Standard Deviation 7.1	18.3 (g/[m2hr]) Standard Deviation 8.6
Transepidermal Water Loss (TEWL) Average TEWL (g/[m2hr]) at 6 months	15.9 (g/[m2hr]) Standard Deviation 5.6	16.1 (g/[m2hr]) Standard Deviation 6.2
Transepidermal Water Loss (TEWL) Average TEWL (g/[m2hr]) at 12 months	13.9 (g/[m2hr]) Standard Deviation 2.3	16.7 (g/[m2hr]) Standard Deviation 5.6

SECONDARY outcome

Timeframe: 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.

Determination of stratum corneum hydration from the dorsal forearm

Outcome measures

Measure	Cetaphil Restoraderm n=32 Participants 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.	Standard of Care n=24 Participants 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.
Skin Hydration (Skin Electrical Capacitance) Average capacitance at 2 months	55.2 farads Standard Deviation 14.0	53.9 farads Standard Deviation 8.2
Skin Hydration (Skin Electrical Capacitance) Average capacitance at 6 months	51.8 farads Standard Deviation 9.8	52.1 farads Standard Deviation 6.1
Skin Hydration (Skin Electrical Capacitance) Average capacitance at 12 months	49.4 farads Standard Deviation 12.7	53.7 farads Standard Deviation 14.0

SECONDARY outcome

Timeframe: 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.

Skin pH, as measured using a pH probe

Outcome measures

Measure	Cetaphil Restoraderm n=32 Participants 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.	Standard of Care n=24 Participants 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.
Skin pH Average pH at 2 months	5.5 pH Standard Deviation 0.4	5.2 pH Standard Deviation 0.4
Skin pH Average pH at 6 months	5.3 pH Standard Deviation 0.6	5.4 pH Standard Deviation 0.5
Skin pH Average pH at 12 months	5.4 pH Standard Deviation 0.7	5.4 pH Standard Deviation 0.5

POST_HOC outcome

Timeframe: 24 Months

Population: Number of participants analyzed captures only those participants still on study at 24 months.

Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months

Outcome measures

Measure	Cetaphil Restoraderm n=31 Participants 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.	Standard of Care n=29 Participants 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.
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months	19.4 percentage of participants	31.0 percentage of participants

Adverse Events

Cetaphil Restoraderm

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cetaphil Restoraderm n=54 participants at risk 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.	Standard of Care n=46 participants at risk 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.
Nervous system disorders Idiopathic Intracranial Hypertension	1.9% 1/54 • Number of events 1 • From the time informed consent is signed through the 24 month study follow-up telephone call.	0.00% 0/46 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Respiratory, thoracic and mediastinal disorders RSV and Stridor	1.9% 1/54 • Number of events 1 • From the time informed consent is signed through the 24 month study follow-up telephone call.	0.00% 0/46 • From the time informed consent is signed through the 24 month study follow-up telephone call.

Other adverse events

Measure	Cetaphil Restoraderm n=54 participants at risk 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.	Standard of Care n=46 participants at risk 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.
Skin and subcutaneous tissue disorders Baby Acne	5.6% 3/54 • Number of events 3 • From the time informed consent is signed through the 24 month study follow-up telephone call.	2.2% 1/46 • Number of events 1 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Viral exanthems	9.3% 5/54 • Number of events 5 • From the time informed consent is signed through the 24 month study follow-up telephone call.	4.3% 2/46 • Number of events 2 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Heat rash/miliaria	7.4% 4/54 • Number of events 4 • From the time informed consent is signed through the 24 month study follow-up telephone call.	6.5% 3/46 • Number of events 3 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Candidiasis	11.1% 6/54 • Number of events 6 • From the time informed consent is signed through the 24 month study follow-up telephone call.	17.4% 8/46 • Number of events 8 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Diaper dermatitis	13.0% 7/54 • Number of events 7 • From the time informed consent is signed through the 24 month study follow-up telephone call.	10.9% 5/46 • Number of events 5 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Seborrheic Dermatitis	16.7% 9/54 • Number of events 9 • From the time informed consent is signed through the 24 month study follow-up telephone call.	17.4% 8/46 • Number of events 8 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Bacterial Skin Infection	7.4% 4/54 • Number of events 4 • From the time informed consent is signed through the 24 month study follow-up telephone call.	6.5% 3/46 • Number of events 3 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Unspecified Transient Rashes	16.7% 9/54 • Number of events 9 • From the time informed consent is signed through the 24 month study follow-up telephone call.	6.5% 3/46 • Number of events 3 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Rash to Vaccination/Drug Rash	3.7% 2/54 • Number of events 2 • From the time informed consent is signed through the 24 month study follow-up telephone call.	0.00% 0/46 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Irritant Contact Dermatitis	9.3% 5/54 • Number of events 5 • From the time informed consent is signed through the 24 month study follow-up telephone call.	4.3% 2/46 • Number of events 2 • From the time informed consent is signed through the 24 month study follow-up telephone call.
Skin and subcutaneous tissue disorders Urticarial Rash	5.6% 3/54 • Number of events 3 • From the time informed consent is signed through the 24 month study follow-up telephone call.	4.3% 2/46 • Number of events 2 • From the time informed consent is signed through the 24 month study follow-up telephone call.

Additional Information

Eric Simpson, MD, MCR

Oregon Health & Science University

Phone: 503-494-3968

Email: simpsone@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place