Xerosis and Use of Topical Moisturizer

Xerosis Due to Atopic Dermatitis Clinical Trial

Official title:

Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Xerosis Following Application of a Topical Moisturizer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341623
• Other study ID #: IRB00062695
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Xerosis Due to Atopic Dermatitis

Intervention

Other:
• Cetaphil Pro Eczema moisturizer
All 30 patients to receive

Behavioral:
• Electronic interaction
10 patients to electronic surveys about moisturizer use
• GPSkin
Measuring moisture in the skin

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Department of Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xerosis Severity	Dry Skin/Ichthyosis Area and Severity Index (DASI)	At Baseline
Primary	Xerosis Severity	Dry Skin/Ichthyosis Area and Severity Index (DASI)	Change from Baseline to 3 months
Primary	Adherence - Moisturizer	MEMs data of daily use of moisturizer	3 months
Primary	Adherence - Moisturizer	Weight of moisturizer	Baseline
Primary	Adherence - Moisturizer	Weight of moisturizer	Change from baseline to 3 months
Primary	Transepidermal water loss (TEWL) rates	Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates	Baseline
Primary	Transepidermal water loss (TEWL) rates	Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates	Change from baseline to 3 month