Xerosis and Use of Topical Moisturizer

NCT04341623 | Active Not Recruiting

• 1 other identifier: IRB00062695
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Xerosis Due to Atopic Dermatitis

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Control Group

OTHER

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

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.

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.

Other: Cetaphil Pro Eczema moisturizer; Behavioral: GPSkin

Interventions

Cetaphil Pro Eczema moisturizer OTHER

All 30 patients to receive

Control Group; Digital Interaction Group; GPSkin group

GPSkin BEHAVIORAL

Measuring moisture in the skin

GPSkin group

Electronic interaction BEHAVIORAL

10 patients to electronic surveys about moisturizer use

Digital Interaction Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects under 18 years of age.
• Subject does not have a working knowledge of English.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Galderma R&D: collaborator

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All three arms will be done at one time

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: January 21, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)