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Xerosis and Use of Topical Moisturizer

NCT ID: NCT04341623

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2026-08-31

Brief Summary

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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

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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

Conditions

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Xerosis Due to Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

All three arms will be done at one time
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis

Group Type OTHER

Cetaphil Pro Eczema moisturizer

Intervention Type OTHER

All 30 patients to receive

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.

Group Type OTHER

Cetaphil Pro Eczema moisturizer

Intervention Type OTHER

All 30 patients to receive

Electronic interaction

Intervention Type BEHAVIORAL

10 patients to electronic surveys about moisturizer use

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.

Group Type OTHER

Cetaphil Pro Eczema moisturizer

Intervention Type OTHER

All 30 patients to receive

GPSkin

Intervention Type BEHAVIORAL

Measuring moisture in the skin

Interventions

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Cetaphil Pro Eczema moisturizer

All 30 patients to receive

Intervention Type OTHER

Electronic interaction

10 patients to electronic surveys about moisturizer use

Intervention Type BEHAVIORAL

GPSkin

Measuring moisture in the skin

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00062695

Identifier Type: -

Identifier Source: org_study_id