- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07270965
Moisturization and Skin Hydration Study
Understanding the Effect of Pre-Drying Moisturization on Skin Hydration
Skin moisturization is important for patients with atopic dermatitis, commonly known as eczema. Moisturizing right after bathing is widely accepted as the best method to keep skin hydrated. However, there is conflicting research on the timing of moisturizing. The goal of this clinical study is to evaluate the preference of moisturizing while showering/bathing compared to after towel drying in adolescents aged 12-18 with eczema. The main question it aims to answer are:
- Which moisturization technique is preferred: while showering/bathing or after towel drying?
- How do these techniques affect investigator-assessed eczema severity, patient-reported itch scores, and objective skin hydration measurements?
Researchers will compare applying moisturizer while in the shower/bath to after towel drying and to which technique is preferred among participants and if there are different effects on eczema and skin hydration.
Participants will:
- Apply moisturizer while showering/bathing for one month and after towel drying for one month.
- Complete questionnaires on moisturization technique, skin feel, and itchiness.
- Undergo skin hydration measurements using a Corneometer® CM825 device.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wingfield Rehmus, MD, MPH
- Phone Number: 1-604-875-2606
- Email: dermatologyresearch@cw.bc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- BC Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have a diagnosis of atopic dermatitis/eczema.
- Participants must be between the age of 12-18.
- Participants must be able to bathe independently.
- Participants will be English speaking and able to complete questionnaires.
Exclusion Criteria:
- Participants who use topical corticosteroids between one inch above the wrist and 1 inch below the elbow from 1 month on both arms prior to the study until the final visit.
- Participants who have a known allergy to the moisturizer cream (Cerave Moisturizing Cream) provided.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moisturizing while in shower/bath
|
Applying moisturizer in the shower/bath.
|
|
Experimental: Moisturizing after towel drying
|
Applying moisturizer out of the shower/bath after towel drying.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants Preferring Each Moisturization Technique
Time Frame: Through study completion, an average of 2 months.
|
Participant reported preference of moisturization technique
|
Through study completion, an average of 2 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Hydration Level
Time Frame: Through study completion, an average of 2 months.
|
Skin electrical capacitance measured using Corneometer® CM825 as an indicator of skin hydration.
|
Through study completion, an average of 2 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eczema Severity Score
Time Frame: Through study completion, an average of 2 months.
|
Eczema severity will be assessed by clinicians using the Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD™).
Scores range from 1 to 4, with higher scores indicating more severe eczema/atopic dermatitis (worse outcome).
|
Through study completion, an average of 2 months.
|
|
Itch Intensity
Time Frame: Through study completion, an average of 2 months.
|
Itch intensity will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 1 to 10, where higher scores indicate greater itch severity (worse outcome).
Participants will report both average itch and worst itch experienced within the past 24 hours.
|
Through study completion, an average of 2 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-02646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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