Xerosis Due to Atopic DermatitisNCT04341623
Xerosis and Use of Topical Moisturizer
A study testing Cetaphil Pro Eczema moisturizer, Electronic interaction and GPSkin in people with Xerosis Due to Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Xerosis Due to Atopic Dermatitis
- What is being tested?
- Cetaphil Pro Eczema moisturizer, Electronic interaction and GPSkin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects under 18 years of age.
- Subject does not have a working knowledge of English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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
- Conditions
- Xerosis Due to Atopic Dermatitis
- Being tested
- Cetaphil Pro Eczema moisturizer, Electronic interaction, GPSkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetaphil Pro Eczema moisturizerOther
All 30 patients to receive
Electronic interactionBehavioural
10 patients to electronic surveys about moisturizer use
GPSkinBehavioural
Measuring moisture in the skin
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis Receives: Other: Cetaphil Pro Eczema moisturizer |
| Digital Interaction Group | Other | 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. Receives: Other: Cetaphil Pro Eczema moisturizer; Behavioral: Electronic interaction |
| GPSkin group | Other | 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. Receives: Other: Cetaphil Pro Eczema moisturizer; Behavioral: GPSkin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerosis Severity
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Measured: At Baseline
Xerosis Severity
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Measured: Change from Baseline to 3 months
Adherence - Moisturizer
MEMs data of daily use of moisturizer
Measured: 3 months
Adherence - Moisturizer
Weight of moisturizer
Measured: Baseline
Adherence - Moisturizer
Weight of moisturizer
Measured: 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
Measured: Baseline
Transepidermal water loss (TEWL) rates
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
Measured: Change from baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start21 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerosis Due to Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- All three arms will be done at one time
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341623
- Sponsor's protocol ID
- IRB00062695
- Status last verified
- Nov 2026
- First submitted
- 8 Apr 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Team will determine what will be shared at later time
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Xerosis Following Application of a Topical Moisturizer
- ClinicalTrials.gov ID
- NCT04341623
- Acronym / sponsor ID
- IRB00062695
- Conditions
- Xerosis Due to Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All three arms will be done at one time
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Cetaphil Pro Eczema moisturizerAll patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis |
| Digital Interaction Group | Other | Other: Cetaphil Pro Eczema moisturizer, Behavioral: Electronic interactionThe 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. |
| GPSkin group | Other | Other: Cetaphil Pro Eczema moisturizer, Behavioral: GPSkinThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects under 18 years of age.
- Subject does not have a working knowledge of English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetaphil Pro Eczema moisturizerAll 30 patients to receive | Other | Control Group, Digital Interaction Group, GPSkin group |
| Electronic interaction10 patients to electronic surveys about moisturizer use | Behavioural | Digital Interaction Group |
| GPSkinMeasuring moisture in the skin | Behavioural | GPSkin group |
Primary outcome
Xerosis Severity
Time frame: At Baseline
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Xerosis Severity
Time frame: Change from Baseline to 3 months
Dry Skin/Ichthyosis Area and Severity Index (DASI)
Adherence - Moisturizer
Time frame: 3 months
MEMs data of daily use of moisturizer
Adherence - Moisturizer
Time frame: Baseline
Weight of moisturizer
Adherence - Moisturizer
Time frame: Change from baseline to 3 months
Weight of moisturizer
Transepidermal water loss (TEWL) rates
Time frame: Baseline
Use of the GPSkin Barrier device a portable hydration measurement device that measures TEWL rates
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided. Team will determine what will be shared at later time
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetaphil Pro Eczema moisturizer, Electronic interaction and GPSkin in people with Xerosis Due to Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerosis Severity (time frame: At Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.