Xerosis and Use of Topical Moisturizer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Xerosis Due to Atopic Dermatitis
• Intervention / Treatment: Other: Cetaphil Pro Eczema moisturizer; Behavioral: Electronic interaction; Behavioral: GPSkin

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Galderma R&D
• Investigators: Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: IRB00062695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Team will determine what will be shared at later time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No