Moisturizer Routine Monitoring for Eczema

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular check-ins help people consistently use their moisturizer for eczema, a condition causing dry, itchy patches. Participants with eczema-related dry skin will either fill out weekly surveys, use a device to measure skin moisture daily, or use the moisturizer as usual. All participants will use a special topical moisturizer with a monitor to track usage frequency. The goal is to assess whether reminders and tracking enhance consistency in moisturizer use. Individuals with eczema and dry skin who speak English may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to understanding how reminders can improve treatment adherence for eczema.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on moisturizer use for eczema, so it's best to ask the study team for clarification.

What prior data suggests that this protocol is safe for monitoring eczema treatment adherence?

Research has shown that Cetaphil Restoraderm moisturizers are generally safe to use. Most people experience no side effects, though some might feel slight burning, stinging, redness, or irritation. These effects are usually mild and resolve quickly.

The moisturizers contain no parabens, fragrances, or steroids, making them gentle on sensitive skin, such as skin prone to eczema. Dermatologists have tested them, and the National Eczema Association has approved them, indicating suitability for people with eczema.

In summary, most people find Cetaphil Restoraderm moisturizers safe and effective, particularly for dry, itchy skin. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to monitor and improve treatment adherence for eczema. Unlike traditional approaches that rely solely on patient self-reporting or occasional check-ins, this trial uses digital surveys and the GPSkin Barrier® device to provide real-time feedback on moisturizer use and skin hydration. These tools could lead to better personalized treatment plans by offering precise data on how well patients stick to their moisturizing routines and how effective these routines are in managing their eczema symptoms.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that moisturizers play a crucial role in treating eczema by strengthening the skin's barrier and increasing hydration. One study found that applying a moisturizer reduced dryness and improved patients' quality of life. On average, patients experienced a decrease in dryness scores from 1.9 to 1.4, indicating a clear improvement. Despite using moisturizers only about 46% of the time, most patients still benefited. Various types of moisturizers, including lotions, creams, gels, and ointments, proved equally effective in relieving eczema symptoms. Regular use of moisturizers can effectively manage eczema. Participants in this trial will be monitored for their use of Cetaphil Pro Eczema moisturizer, with some groups receiving additional digital interaction or moisture level measurement to assess adherence and effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with dry skin (xerosis) related to eczema or atopic dermatitis, who can communicate in English. It's not suitable for those under 18 or without a working knowledge of English.

Inclusion Criteria

I have dry skin due to current or past eczema.

Subject has a working knowledge of English.

Exclusion Criteria

I am under 18 years old.

Subject does not have a working knowledge of English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Baseline moisture level of the inner wrist, inner elbow, and dorsal hand is measured using the GPSkin Barrier® device

1 day

1 visit (in-person)

Treatment

Participants receive Cetaphil Pro Eczema moisturizer with adherence monitored electronically. Randomized into control, digital interaction, or GPSkin group.

3 months

Weekly electronic survey for digital interaction group, daily monitoring for GPSkin group

Follow-up

Participants return for data collection on adherence, moisturizer weight, and hydration level measurement

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Use of Topical Moisturizer

Trial Overview The study tests if monitoring skin hydration and water loss helps people stick to using Cetaphil Pro Eczema moisturizer daily. Participants will either get no extra help, answer weekly surveys, or use a device (GPSkin) that checks how well the moisturizer works.

How Is the Trial Designed?

Group I: GPSkin group Experimental Treatment 2 Interventions

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.

Group II: Digital Interaction Group Experimental Treatment 2 Interventions

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.

Group III: Control Group Experimental Treatment 1 Intervention

All patients will receive Cetaphil Pro Eczema moisturizer equipped with an electronic monitor to measure adherence to daily treatment of xerosis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Galderma R&D

Industry Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a study involving 174 overweight and obese participants, the DietMatePro app showed a higher adherence rate to the Ornish Prevention Diet (43%) compared to a traditional paper food diary (28%), suggesting it may help people stick to their dietary plans better.

While DietMatePro did not provide more accurate dietary data than the paper diary, it still proved beneficial in improving adherence to dietary regimens, indicating its potential as a useful tool for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a PDA-based dietary assessment and intervention program: a randomized controlled trial. Beasley, JM., Riley, WT., Davis, A., et al.[2022]

Common moisturizers like Aveeno, Cetaphil, and Cerave contain multiple potential allergens, with 12, 14, and 9 allergens respectively, most of which are infrequent and not included in standard allergy tests.

Awareness of these allergens can aid healthcare providers in diagnosing allergic contact dermatitis (ACD) in patients, especially when standard patch tests yield negative results or when ACD does not respond to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic Contact Dermatitis Secondary to Moisturizers. Cohen, SR., Cárdenas-de la Garza, JA., Dekker, P., et al.[2021]

Atopic dermatitis (AD) affects 10-20% of school-aged children and has seen a significant increase in prevalence over the past three decades, leading to considerable physical, psychological, and financial burdens on families.

Effective management of AD relies on preventive measures like regular moisturizer application to reduce flare-ups, and when these fail, therapeutic options such as topical corticosteroids and new ceramide-based products are available, although many cosmetic claims lack robust clinical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ceramides and related products for childhood-onset eczema. Hon, KL., Leung, AK.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5574736/

Performance and Tolerability of the Moisturizers Cetaphil ... Moisturizers play a prominent role in the management of atopic dermatitis by improving the impaired skin barrier function and enhancing skin hydration.

2. jddonline.com jddonline.com/articles/topical-moisturizer-meaningfully-reduces-disease-severity-in-atopic-patients-with-xerosis-S1545961623P0e51X/

Topical Moisturizer Meaningfully Reduces Disease ... Results: Mean adherence to the moisturizer was 46%. Dryness improved from 1.9 at baseline to 1.4 at follow-up (P=0.02). DLQI improved from 3.3 at baseline to ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK544513/

Emollient Treatments for Atopic Dermatitis: A Review of ... - NCBI Two systematic reviews concluded that emollients were beneficial in the treatment of atopic dermatitis, but that there was insufficient evidence to recommend ...

4. annallergy.org annallergy.org/article/S1081-1206(23)01455-2/fulltext

Atopic dermatitis (eczema) guidelines: 2023 American ... These evidence-based recommendations address optimal use of (1) topical treatments (barrier moisturization devices, corticosteroids, calcineurin ...

5. thelancet.com thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00146-8/fulltext

Effectiveness and safety of lotion, cream, gel, and ointment ... There was no difference in eczema symptoms between lotions, creams, gels, or ointments over 16 weeks. This finding was robust to sensitivity ...

6. cetaphil.com cetaphil.com/us/products/product-categories/all-moisturizers/restoraderm-eczema-soothing-moisturizer/302990230208.html

Restoraderm Eczema Soothing Moisturizer Free of parabens, fragrances and steroids, this gentle moisturizing lotion is dermatologist tested and accepted by the National Eczema Association to be ...

7. webmd.com webmd.com/drugs/2/drug-159862/cetaphil-restoraderm-topical/details

Cetaphil Restoraderm Lotion - Uses, Side Effects, and More Most emollients can be used safely and effectively with no side effects. However, burning, stinging, redness, or irritation may occur. If any of these effects ...

8. amazon.com amazon.com/RESTORADERM-Moisturizer-Flare-Ups-Hydration-Protectant/dp/B09Y3WSY9M

Cetaphil ECZEMA RESTORADERM Soothing Moisturizer ... This lotion is accepted by the National Eczema Association as gentle on eczema prone skin. eczema. This unique lotion with 1% colloidal oatmeal helps relieve ...

9. allergyfoundation.co.za allergyfoundation.co.za/product/cetaphil-pro-eczema-prone-skin-skin-restoring-moisturizer/

Cetaphil® Pro Eczema-Prone Skin, Skin Restoring ... A moisturiser designed to meet the specific needs of children and adults with dry, itchy skin. Its ingredients (filaggrin and substances to promote ceramide)