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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Use of Topical Moisturizer for eczema?

Research shows that using moisturizers can help reduce the number of eczema flare-ups and the need for other medications like corticosteroids. Moisturizers containing ingredients like glycyrrhetinic acid, urea, and glycerol have been found to be more effective than not using any moisturizer. ^{1 2 3 4 5}

Is using a moisturizer generally safe for people with eczema?

Moisturizers are generally safe for people with eczema, but some individuals may experience allergic reactions, known as allergic contact dermatitis, to certain ingredients in moisturizers. It's important to be aware of potential allergens in the products used. ^{1 6 7 8 9}

How is the use of topical moisturizer for eczema different from other treatments?

The use of topical moisturizer for eczema is unique because it focuses on maintaining skin hydration and barrier function, which can help reduce flare-ups and irritation. Unlike some other treatments that may involve steroids or other medications, moisturizers are generally gentle and can be used regularly without significant side effects. ^{10 11 12 13 14}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Emollients and moisturizers for eczema: abridged Cochrane systematic review including GRADE assessments. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Moisturizer effect on irritant dermatitis: an overview. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. [2022]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Use of ceramides and related products for childhood-onset eczema. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Parental knowledge of moisturizers and their application to infants with eczema in Hangzhou, China. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin. [2022]

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8. England pubmed.ncbi.nlm.nih.gov

The efficacy of different moisturizers on barrier recovery in hairless mice evaluated by non-invasive bioengineering methods. A model to select the potentially most effective product. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Allergic Contact Dermatitis Secondary to Moisturizers. [2021]

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11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a PDA-based dietary assessment and intervention program: a randomized controlled trial. [2022]

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The Eating Pattern Assessment Tool: a simple instrument for assessing dietary fat and cholesterol intake. [2019]

13. France pubmed.ncbi.nlm.nih.gov

[How valid are food surveys run by dieticians?]. [2009]

14. United States pubmed.ncbi.nlm.nih.gov

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