Xerosis and Use of Topical Moisturizer
Primary Purpose
Xerosis Due to Atopic Dermatitis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cetaphil Pro Eczema moisturizer
Electronic interaction
GPSkin
Sponsored by
About this trial
This is an interventional other trial for Xerosis Due to Atopic Dermatitis
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.
Sites / Locations
- Wake Forest University Health Sciences Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control Group
Digital Interaction Group
GPSkin group
Arm Description
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 in addition to the electronic monitor measuring the adherence.
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.
Outcomes
Primary Outcome Measures
Xerosis Severity
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Xerosis Severity
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Adherence - Moisturizer
MEMs data of daily use of moisturizer
Adherence - Moisturizer
Weight of moisturizer
Adherence - Moisturizer
Weight of moisturizer
Transepidermal water loss (TEWL) rates
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Transepidermal water loss (TEWL) rates
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Secondary Outcome Measures
Full Information
NCT ID
NCT04341623
First Posted
April 8, 2020
Last Updated
September 18, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Galderma R&D
1. Study Identification
Unique Protocol Identification Number
NCT04341623
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerosis Due to Atopic Dermatitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
All three arms will be done at one time
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis
Arm Title
Digital Interaction Group
Arm Type
Other
Arm Description
The digital interaction group will receive a survey by email each week asking about their Cetaphil use in addition to the electronic monitor measuring the adherence.
Arm Title
GPSkin group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cetaphil Pro Eczema moisturizer
Intervention Description
All 30 patients to receive
Intervention Type
Behavioral
Intervention Name(s)
Electronic interaction
Intervention Description
10 patients to electronic surveys about moisturizer use
Intervention Type
Behavioral
Intervention Name(s)
GPSkin
Intervention Description
Measuring moisture in the skin
Primary Outcome Measure Information:
Title
Xerosis Severity
Description
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Time Frame
At Baseline
Title
Xerosis Severity
Description
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Time Frame
Change from Baseline to 3 months
Title
Adherence - Moisturizer
Description
MEMs data of daily use of moisturizer
Time Frame
3 months
Title
Adherence - Moisturizer
Description
Weight of moisturizer
Time Frame
Baseline
Title
Adherence - Moisturizer
Description
Weight of moisturizer
Time Frame
Change from baseline to 3 months
Title
Transepidermal water loss (TEWL) rates
Description
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Time Frame
Baseline
Title
Transepidermal water loss (TEWL) rates
Description
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Time Frame
Change from baseline to 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Team will determine what will be shared at later time
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Xerosis and Use of Topical Moisturizer
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