Clinical trial NCT04341623: Xerosis and Use of Topical Moisturizer
Official title: Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Xerosis Following Application of a Topical Moisturizer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Xerosis Due to Atopic Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2020-04-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All three arms will be done at one time
Primary purpose: OTHER

Brief summary: The primary hypothesis is that routine measurement of trans epidermal water loss (TEWL) rates and stratum corneum (SC) hydration levels will promote patient adherence to maintenance moisturizer therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with xerosis receive moisturizer therapy and are randomized to receive either no intervention, a weekly electronic survey to assess patient's response to daily moisturizer, or daily monitoring of the effectiveness of a moisturizer with a portable hydration measurement device. The study team will measure adherence to daily moisturizer use objectively in all three groups with electronic monitors attached to the containers of the moisturizer. The adherence measure will allow the study determine how well moisturizers work for xerosis when that are well used. The study team anticipate that in the no intervention group, adherence will be abysmal and that in the group reporting their response to treatment weekly, adherence will be much better. This will give the study team negative and positive controls for assessing the effect of home barrier monitoring on treatment adherence.

Detailed description: Adult subjects will be offered an opportunity to participate in the study. Subjects will have a diagnosis of xerosis in the context (current or historic) of atopic dermatitis. A total of 30 subjects will be enrolled. After consent and basic demographics, a study team member will use the GPSkin Barrier® device to measure the baseline moisture level of the inner wrist, inner elbow, and dorsal hand of all subjects. Subjects will also fill out questionnaires pertaining to quality of life, measures of predictors of adherence, and severity of xerosis.

Subjects will be randomized into one of three arms: the control group (n= 10), the electronic interaction group to assess patient's response to daily moisturizer (n=10), or the GPSkin group (n=10). All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis. The digital interaction group will receive a survey by email each week asking about their Cetaphil use. The patients in the GPSkin group will receive the GPSkin Barrier® to measure the moisture level of their inner wrist, inner elbow, and dorsal hand daily. Subjects will be instructed to use the Cetaphil once daily. Subjects will return at 3 months. At this visit, the data from the electronic adherence monitoring will be downloaded, the Cetaphil will be weighed, the patient will fill out the same questionnaires (quality of life, measures of predictors of adherence, and severity of xerosis), and the stratum corneum hydration level will be measured. The intervention subjects will be evaluated on their use of the GPSkin Barrier® to measure their stratum corneum hydration

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older.
* Subject has a working knowledge of English.
* Subject with a diagnosis of xerosis in the context (current or historic) of atopic dermatitis

Exclusion Criteria:

* Subjects under 18 years of age.
* Subject does not have a working knowledge of English.

Primary outcomes:
measure: Xerosis Severity
timeFrame: At Baseline
measure: Xerosis Severity
timeFrame: Change from Baseline to 3 months
measure: Adherence - Moisturizer
timeFrame: 3 months
measure: Adherence - Moisturizer
timeFrame: Baseline
measure: Adherence - Moisturizer
timeFrame: Change from baseline to 3 months
measure: Transepidermal water loss (TEWL) rates
timeFrame: Baseline
measure: Transepidermal water loss (TEWL) rates
timeFrame: Change from baseline to 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: