Atopic DermatitisNCT01375205
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
A study testing Cetaphil Restoraderm in people with Atopic Dermatitis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 weeks
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cetaphil Restoraderm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, 97239
About this study
Official title: A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Cetaphil Restoraderm, Standard of Care
- Keywords
- atopic dermatitis, skin care
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetaphil RestoradermOther
Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
Standard of CareOther
Also called Johnson&Johnson
Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser. Receives: Other: Standard of Care |
| Cetaphil Restoraderm | Experimental | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. Receives: Other: Cetaphil Restoraderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 2, 6, 12, 18, and 24 months
Age at Onset of Eczema
Age of subject at onset of eczema
Measured: Baseline through Month 24 Follow-up
Filaggrin Mutation Status
Filaggrin mutation status result
Measured: 6 month visit
Transepidermal Water Loss (TEWL)
Transepidermal water loss (TEWL) to measure skin barrier function
Measured: 2 month, 6 month, and 12 month visits
Skin Hydration (Skin Electrical Capacitance)
Determination of stratum corneum hydration from the dorsal forearm
Measured: 2 month, 6 month, and 12 month visits
Skin pH
Skin pH, as measured using a pH probe
Measured: 2 month, 6 month, and 12 month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Eric Simpson, Oregon Health and Science University
- Investigators
- Eric Simpson, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375205
- Sponsor's protocol ID
- Galderma Cetaphil Restoraderm
- Status last verified
- Jan 2020
- First submitted
- 15 Jun 2011
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01375205
- Acronym / sponsor ID
- Galderma Cetaphil Restoraderm
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, skin care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Jun 2011 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Posted 12 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareSubjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser. |
| Cetaphil Restoraderm | Experimental | Other: Cetaphil RestoradermSubjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetaphil RestoradermSubjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. | Other | Cetaphil Restoraderm |
| Standard of CareAlso: Johnson&JohnsonSubjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser. | Other | Standard of Care |
Primary outcome
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
Time frame: 12 months
Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months
6 secondary outcomes
Percentage of High Emollient Use
Time frame: 2, 6, 12, 18, and 24 months
Age at Onset of Eczema
Time frame: Baseline through Month 24 Follow-up
Filaggrin Mutation Status
Time frame: 6 month visit
Transepidermal Water Loss (TEWL)
Time frame: 2 month, 6 month, and 12 month visits
Skin Hydration (Skin Electrical Capacitance)
Time frame: 2 month, 6 month, and 12 month visits
Skin pH
Time frame: 2 month, 6 month, and 12 month visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Simpson, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetaphil Restoraderm in people with Atopic Dermatitis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.