Dermatitis, AtopicPhase 1NCT03663673
Effect of Different Skin Creams on TEWL
A Phase 1 study testing EpiCeram and Aveeno Daily Moisturising Sheer Hydration Lotion® in people with Dermatitis, Atopic, run by Stanford University at 1 site in United States.
Trial summary
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®. Read more about this study
- Who is it for?
- Ages 1 day to 40 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- EpiCeram and Aveeno Daily Moisturising Sheer Hydration Lotion®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 18 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
- Male or female participants, between the ages of 0 to 40 years will be included
- Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score > 26) without a history or current manifestations of eczema herpeticum (EH)
- AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)
Who cannot join
- Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
- Participants with skin disease other than AD that might compromise the stratum corneum barriers (e.g., bullous diseases, psoriasis, cutaneous T-cell lymphoma (also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- Known or suspected immunosuppression
- Severe concomitant illness(es)
- History of serious life-threatening reaction to latex, tape, or adhesives
- Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days of the Enrollment Visit
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- Use of topical corticosteroids, topical immunomodulatory agents (such as calcineural inhibitors and crisaborole), or topical antibiotics on the upper or lower extremities within 7 days of the Enrollment Visit
- Has taken a bleach bath within 7 days of the Enrollment Visit
- Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sean N Parker Center For Allergy and Asthma Research
Mountain View, California, 94040
About this study
Official title: Comparison of Two Different Skin Creams and Their Effect on Transepidermal Water Loss (TEWL) in Pediatric and Adult Patients With Atopic Dermatitis: A Pilot Study
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Read the detailed description
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no emollient use for one week.
Secondary Objectives: To assess lipid and protein profiles of skin tape strips from non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no treatment.
Exploratory Objectives :
- To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
- To evaluate whether baseline food and environmental allergy sensitization (assessed via skin prick testing during screening) affects the outcomes. See protocol section 3.1 for allergen details.
- A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.
- Conditions
- Dermatitis, Atopic
- Being tested
- EpiCeram, Aveeno Daily Moisturising Sheer Hydration Lotion®
- Keywords
- Dermatitis, emollient, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCeramDrug
To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
Aveeno Daily Moisturising Sheer Hydration Lotion®Drug
To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
| Study group | Role | What they receive |
|---|---|---|
| Clinical pilot study | Other | To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week. Receives: Drug: EpiCeram; Drug: Aveeno Daily Moisturising Sheer Hydration Lotion® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier function
Skin barrier function, assessed by TEWL
Measured: 2 weeks
Secondary outcomes (1)
Baseline food and environmental allergy sensitization
Skin prick testing
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Sep 2018
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Stanford 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- End Allergies Together (EAT)
- Responsible party
- Principal investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Sayantani Sindher, M.D., Principal investigator, Stanford Health CareKari Nadeau, M.D., PhD, Study chair, Stanford Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663673
- Sponsor's protocol ID
- SNP 47028
- Status last verified
- Aug 2021
- First submitted
- 6 Sep 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Skin Creams and Their Effect on Transepidermal Water Loss (TEWL) in Pediatric and Adult Patients With Atopic Dermatitis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03663673
- Acronym / sponsor ID
- SNP 47028
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, emollient, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- End Allergies Together (EAT)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Detailed description
Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no emollient use for one week.
Secondary Objectives: To assess lipid and protein profiles of skin tape strips from non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no treatment.
Exploratory Objectives :
- To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
- To evaluate whether baseline food and environmental allergy sensitization (assessed via skin prick testing during screening) affects the outcomes. See protocol section 3.1 for allergen details.
- A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
| Arm | Type | Receives |
|---|---|---|
| Clinical pilot study | Other | Drug: EpiCeram, Drug: Aveeno Daily Moisturising Sheer Hydration Lotion®To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week. |
Who may qualify
- Ages
- 1 day to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
- Male or female participants, between the ages of 0 to 40 years will be included
- Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score > 26) without a history or current manifestations of eczema herpeticum (EH)
- AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)
Key exclusion criteria (9 listed)
- Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
- Participants with skin disease other than AD that might compromise the stratum corneum barriers (e.g., bullous diseases, psoriasis, cutaneous T-cell lymphoma (also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
- Known or suspected immunosuppression
- Severe concomitant illness(es)
- History of serious life-threatening reaction to latex, tape, or adhesives
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 |
|---|---|---|
| EpiCeramTo compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week. | Drug | Clinical pilot study |
| Aveeno Daily Moisturising Sheer Hydration Lotion®To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week. | Drug | Clinical pilot study |
Primary outcome
Skin barrier function
Time frame: 2 weeks
Skin barrier function, assessed by TEWL
1 secondary outcome
Baseline food and environmental allergy sensitization
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Sayantani Sindher, M.D. principal investigator
Stanford Health Care
Kari Nadeau, M.D., PhD study chair
Stanford Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EpiCeram and Aveeno Daily Moisturising Sheer Hydration Lotion® in people with Dermatitis, Atopic, run by Stanford 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 4 inclusion and 9 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 8 Sep 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin barrier function (time frame: 2 weeks). 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 8 Sep 2021.