Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

• ClinicalTrials.gov Identifier: NCT01375205
• Recruitment Status: Completed
• First Posted: June 17, 2011
• Results First Posted: April 12, 2019
• Last Update Posted: February 12, 2020
• Sponsor: Oregon Health and Science University
• Collaborator: Galderma R&D
• Information provided by (Responsible Party): Eric Simpson, Oregon Health and Science University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other
• Condition: Atopic Dermatitis
• Interventions: Other: Cetaphil Restoraderm; Other: Standard of Care
• Enrollment: 100

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	54	46
Completed	33	33
Not Completed	21	13
Reason Not Completed
Lost to Follow-up	15	12
Withdrawal by Subject	6	1

Baseline Characteristics

Arm/Group Title		Cetaphil Restoraderm	Standard of Care	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		54	46	100
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	54 participants	46 participants	100 participants
	<=18 years	54 100.0%	46 100.0%	100 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	54 participants	46 participants	100 participants
	Female	24 44.4%	25 54.3%	49 49.0%
	Male	30 55.6%	21 45.7%	51 51.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	54 participants	46 participants	100 participants
		54	46	100

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
Description	Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	38	32
Measure Type: Number; Unit of Measure: Percentage of participants
	13.2	25

2. Secondary Outcome

Title	Percentage of High Emollient Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	54	46
Measure Type: Number; Unit of Measure: percentage of participants
Percentage of high emollient use at 2 months	87	45.2
Percentage of high emollient use at 6 months	72.4	45.8
Percentage of high emollient use at 12 months	66.7	45.5
Percentage of high emollient use at 18 months	52.2	53.3
Percentage of high emollient use at 24 months	40.0	33.3

3. Secondary Outcome

Title	Age at Onset of Eczema
Description	Age of subject at onset of eczema
Time Frame	Baseline through Month 24 Follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	54	46
Median (Full Range); Unit of Measure: months
	4; (0 to 24)	6; (0 to 24)

4. Secondary Outcome

Title	Filaggrin Mutation Status
Description	Filaggrin mutation status result
Time Frame	6 month visit

Outcome Measure Data

Analysis Population Description

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/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	25	31
Measure Type: Count of Participants; Unit of Measure: Participants
Positive for Filaggrin Mutation	3 12.0%	2 6.5%
Negative for Filaggrin Mutation	22 88.0%	29 93.5%

5. Secondary Outcome

Title	Transepidermal Water Loss (TEWL)
Description	Transepidermal water loss (TEWL) to measure skin barrier function
Time Frame	2 month, 6 month, and 12 month visits

Outcome Measure Data

Analysis Population Description

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/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	32	24
Mean (Standard Deviation); Unit of Measure: (g/[m2hr])
Average TEWL (g/[m2hr]) at 2 months	16.3 (7.1)	18.3 (8.6)
Average TEWL (g/[m2hr]) at 6 months	15.9 (5.6)	16.1 (6.2)
Average TEWL (g/[m2hr]) at 12 months	13.9 (2.3)	16.7 (5.6)

6. Secondary Outcome

Title	Skin Hydration (Skin Electrical Capacitance)
Description	Determination of stratum corneum hydration from the dorsal forearm
Time Frame	2 month, 6 month, and 12 month visits

Outcome Measure Data

Analysis Population Description

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/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	32	24
Mean (Standard Deviation); Unit of Measure: farads
Average capacitance at 2 months	55.2 (14.0)	53.9 (8.2)
Average capacitance at 6 months	51.8 (9.8)	52.1 (6.1)
Average capacitance at 12 months	49.4 (12.7)	53.7 (14.0)

7. Secondary Outcome

Title	Skin pH
Description	Skin pH, as measured using a pH probe
Time Frame	2 month, 6 month, and 12 month visits

Outcome Measure Data

Analysis Population Description

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/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	32	24
Mean (Standard Deviation); Unit of Measure: pH
Average pH at 2 months	5.5 (0.4)	5.2 (0.4)
Average pH at 6 months	5.3 (0.6)	5.4 (0.5)
Average pH at 12 months	5.4 (0.7)	5.4 (0.5)

8. Post-Hoc Outcome

Title	Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months
Description	Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cetaphil Restoraderm	Standard of Care
Arm/Group Description:	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.	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 Number of Participants Analyzed	31	29
Measure Type: Number; Unit of Measure: percentage of participants
	19.4	31.0

Adverse Events

Time Frame	From the time informed consent is signed through the 24 month study follow-up telephone call.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Cetaphil Restoraderm		Standard of Care
Arm/Group Description	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.		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.
All-Cause Mortality
	Cetaphil Restoraderm		Standard of Care
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/54 (0.00%)		0/46 (0.00%)
Serious Adverse Events
	Cetaphil Restoraderm		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/54 (3.70%)		0/46 (0.00%)
Nervous system disorders
Idiopathic Intracranial Hypertension †	1/54 (1.85%)	1	0/46 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
RSV and Stridor †	1/54 (1.85%)	1	0/46 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	Cetaphil Restoraderm		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/54 (55.56%)		21/46 (45.65%)
Skin and subcutaneous tissue disorders
Baby Acne †	3/54 (5.56%)	3	1/46 (2.17%)	1
Viral exanthems †	5/54 (9.26%)	5	2/46 (4.35%)	2
Heat rash/miliaria †	4/54 (7.41%)	4	3/46 (6.52%)	3
Candidiasis †	6/54 (11.11%)	6	8/46 (17.39%)	8
Diaper dermatitis †	7/54 (12.96%)	7	5/46 (10.87%)	5
Seborrheic Dermatitis †	9/54 (16.67%)	9	8/46 (17.39%)	8
Bacterial Skin Infection †	4/54 (7.41%)	4	3/46 (6.52%)	3
Unspecified Transient Rashes †	9/54 (16.67%)	9	3/46 (6.52%)	3
Rash to Vaccination/Drug Rash †	2/54 (3.70%)	2	0/46 (0.00%)	0
Irritant Contact Dermatitis †	5/54 (9.26%)	5	2/46 (4.35%)	2
Urticarial Rash †	3/54 (5.56%)	3	2/46 (4.35%)	2
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Eric Simpson, MD, MCR
• Organization: Oregon Health & Science University
• Phone: 503-494-3968
• EMail: simpsone@ohsu.edu

• Responsible Party: Eric Simpson, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01375205
• Other Study ID Numbers: Galderma Cetaphil Restoraderm
• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Results First Submitted: January 22, 2019
• Results First Posted: April 12, 2019
• Last Update Posted: February 12, 2020