Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cetaphil Restoraderm Standard of Care
Hide 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
Arm/Group Title Cetaphil Restoraderm Standard of Care Total
Hide 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
Hide 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
1.Primary Outcome
Title Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
Hide Description Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Around 28% of subjects enrolled were lost to follow-up by 12 months
Arm/Group Title Cetaphil Restoraderm Standard of Care
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cetaphil Restoraderm Standard of Care
Hide 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
Hide Description Age of subject at onset of eczema
Time Frame Baseline through Month 24 Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cetaphil Restoraderm Standard of Care
Hide 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
Hide Description Filaggrin mutation status result
Time Frame 6 month visit
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description Transepidermal water loss (TEWL) to measure skin barrier function
Time Frame 2 month, 6 month, and 12 month visits
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide Description Determination of stratum corneum hydration from the dorsal forearm
Time Frame 2 month, 6 month, and 12 month visits
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Skin pH, as measured using a pH probe
Time Frame 2 month, 6 month, and 12 month visits
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months
Time Frame 24 Months
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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%)    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Eric Simpson, MD, MCR
Organization: Oregon Health & Science University
Phone: 503-494-3968
EMail: simpsone@ohsu.edu
Layout table for additonal information
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