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NCT Number: NCT04341623

Xerosis and Use of 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Xerosis Due to Atopic Dermatitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetaphil Pro Eczema moisturizer

Other

All 30 patients to receive

Electronic interaction

Behavioral

10 patients to electronic surveys about moisturizer use

GPSkin

Behavioral

Measuring moisture in the skin

Primary outcomes

  1. Xerosis Severity

    Time frame: At Baseline

    Dry Skin/Ichthyosis Area and Severity Index (DASI)

  2. Xerosis Severity

    Time frame: Change from Baseline to 3 months

    Dry Skin/Ichthyosis Area and Severity Index (DASI)

  3. Adherence - Moisturizer

    Time frame: 3 months

    MEMs data of daily use of moisturizer

  4. Adherence - Moisturizer

    Time frame: Baseline

    Weight of moisturizer

  5. Adherence - Moisturizer

    Time frame: Change from baseline to 3 months

    Weight of moisturizer

  6. Transepidermal water loss (TEWL) rates

    Time frame: Baseline

    Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates

  7. Transepidermal water loss (TEWL) rates

    Time frame: Change from baseline to 3 month

    Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2020
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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