NCT04341623|Active Not Recruiting
Xerosis and Use of Topical Moisturizer
Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Xerosis Following Application of a Topical Moisturizer
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Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Xerosis Following Application of a Topical Moisturizer
Sponsor study identifier
interventional
35
1 country
1
Study Start
January 21, 2021
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 8, 2020
Actual (reported)April 10, 2020
Actual (reported)January 21, 2021
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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 in addition to the electronic monitor measuring the adherence.
All 30 patients to receive
10 patients to electronic surveys about moisturizer use
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157, United States
Steven R Feldman, MD, PhD
Wake Forest University Health Sciences
35 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2020
First Posted
April 10, 2020
Study Start
January 21, 2021
Actual (reported)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.
Measuring moisture in the skin
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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