Moisturization and Skin Hydration Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Moisturizing while in shower/bath

    Behavioral

    Applying moisturizer in the shower/bath.

  • Moisturizing after towel drying

    Behavioral

    Applying moisturizer out of the shower/bath after towel drying.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Moisturizing while in shower/bathExperimental treatment 1 intervention
Group B: Moisturizing after towel dryingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Preferring Each Moisturization Technique

Participant reported preference of moisturization technique

Time frame
Through study completion, an average of 2 months.

Secondary outcomes

1

Skin Hydration Level

Skin electrical capacitance measured using Corneometer® CM825 as an indicator of skin hydration.

Time frame
Through study completion, an average of 2 months.

Other outcomes

1

Eczema Severity Score

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).

Time frame
Through study completion, an average of 2 months.
2

Itch Intensity

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.

Time frame
Through study completion, an average of 2 months.

Sponsors and contacts

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