Clinical trial NCT03663673: Effect of Different Skin Creams on TEWL
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Keywords: Dermatitis
emollient
Atopic Dermatitis
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: End Allergies Together (EAT)
First posted: 2018-09-10
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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®.
Primary purpose: TREATMENT

Brief 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®.

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.

Eligibility criteria: Inclusion Criteria:

1. Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
2. Male or female participants, between the ages of 0 to 40 years will be included
3. Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score \> 26) without a history or current manifestations of eczema herpeticum (EH)
4. AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)

Exclusion Criteria:

1. Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
2. 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).
3. Known or suspected immunosuppression
4. Severe concomitant illness(es)
5. History of serious life-threatening reaction to latex, tape, or adhesives
6. 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
7. 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
8. Has taken a bleach bath within 7 days of the Enrollment Visit
9. Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.

Primary outcomes:
measure: Skin barrier function
timeFrame: 2 weeks
Secondary outcomes:
measure: Baseline food and environmental allergy sensitization
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Sean N Parker Center For Allergy and Asthma Research
state: California
Study officials:
affiliation: Stanford Health Care
name: Sayantani Sindher, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Health Care
name: Kari Nadeau, M.D., PhD
role: STUDY_CHAIR
References: