Xerosis and Use of Topical Moisturizer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control Group All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis |
Other: Cetaphil Pro Eczema moisturizer
All 30 patients to receive
|
| Other: Digital Interaction Group 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. |
Other: Cetaphil Pro Eczema moisturizer
All 30 patients to receive
Behavioral: Electronic interaction
10 patients to electronic surveys about moisturizer use
|
| Other: GPSkin group 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. |
Other: Cetaphil Pro Eczema moisturizer
All 30 patients to receive
Behavioral: GPSkin
Measuring moisture in the skin
|
Outcome Measures
Primary Outcome Measures
- Xerosis Severity [At Baseline]
Dry Skin/Ichthyosis Area and Severity Index (DASI)
- Xerosis Severity [Change from Baseline to 3 months]
Dry Skin/Ichthyosis Area and Severity Index (DASI)
- Adherence - Moisturizer [3 months]
MEMs data of daily use of moisturizer
- Adherence - Moisturizer [Baseline]
Weight of moisturizer
- Adherence - Moisturizer [Change from baseline to 3 months]
Weight of moisturizer
- Transepidermal water loss (TEWL) rates [Baseline]
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
- Transepidermal water loss (TEWL) rates [Change from baseline to 3 month]
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is 18 years of age or older.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- Galderma R&D
Investigators
- Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00062695