Individual Article: Over-the-Counter Moisturizers Significantly Improve Skin Hydration in Adults With Eczema/Atopy-Prone Skin

October 2023 | Volume 22 | Issue 10 | SF388641s16 | Copyright © October 2023


Published online September 30, 2023

Harrison Nguyen MD MBA MPHa, Thu Nguyen PhDb, Ana Mantilla DPMb, Christine Emesiani PharmDb, Matthew Meckfessel PhDb

aDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA 
bGalderma Laboratories, L.P., Dallas, TX


Abstract
Background: Many adults suffer from dry, itchy skin, particularly those with eczema-prone skin. This study evaluated the effects of two over-the-counter (OTC) moisturizing products on skin hydration, transepidermal water loss (TEWL), ceramide levels, and patient experience.
Methods: Single-center, randomized, double-blind, split-body study evaluating the effectiveness of an Eczema Soothing Moisturizer (ESM) versus an Itch Relief Moisturizing Lotion (IRML) applied twice daily for 4 weeks in healthy adults with self-perceived persistent mild-to-moderate eczema-prone skin. Assessments included corneometer for skin hydration, evaporimeter for TEWL, tape stripping to measure ceramide NS and AS levels on the skin of the arm and leg, and a self-assessed participant-reported outcome questionnaire.
Results: A total of 30 adults completed the study. Both products significantly increased hydration, but the effect of ESM was greater than IRML (P=0.001), and both significantly decreased TEWL. At week 4, there were increases in NS and AS ceramides at both the legs and arms for both products (P<0.05 vs BL). Individually, ceramide content was significantly improved for ESM in the leg and for IRML in the arm at week 4 (P<0.05 vs BL). Participant photos show ESM was beneficial across a range of skin phototypes. Both products resulted in favorable perceptions from study participants.
Conclusions: These moisturizers improved skin hydration, skin barrier, ceramide levels in the skin, and were well-perceived by the participants. This suggests that both products are beneficial for patients with eczema and eczema-prone skin. However, the hydrating effect of ESM was significantly greater than IRML.

J Drugs Dermatol. 2023;22:10(Suppl 2):s16-20.

INTRODUCTION

Eczema- or atopy-prone skin frequently has an ineffective skin barrier, which can lead to redness, irritation, and dryness with periods of remission interspersed with flares.1 When their eczema flares, patients want rapid relief. Over-the-counter (OTC) moisturizers are a cornerstone of eczema therapy and are useful even between itchy periods to soothe the skin and support the skin barrier.2 Eczema is estimated to affect between 2% and 10% of adults and up to 20% of children.3,4  In recent years there has been substantial increases in the knowledge-base about abnormalities in skin barrier and immune system function.5 However, management of eczema and eczema-prone skin continues to pose a clinical challenge. Eczema and associated pruritus may not only have a pronounced negative effect on sleep patterns and quality of life but can also create a substantial economic burden.6 Existing eczema guidelines highlight the importance of proper cleansing and moisturizing.4 Patients require education about how to cleanse skin thoroughly yet gently.4 It is recommended that topical emollients moisturizers should be applied directly after cleansing. According to Wollenberg et al, proper use of skin care can result in both short- and long-term steroid sparing effects as well as maintenance of stable disease.4 In a recent systematic review, Maleki-Yazdi and colleagues report patients prefer to start with nonmedical treatments before moving to prescription products.7

To be effective in managing eczema symptoms, OTC moisturizing products should support and restore skin barrier function as well as provide itch relief. In addition to OTC product use being recommended in eczema guidelines, Miller et al reported that an OTC moisturizer was as effective as prescription barrier creams, while being less expensive.8 This study evaluated the effectiveness and patient perception of two moisturizers, Eczema Soothing Moisturizer (ESM) and Itch Relief Moisturizing Lotion (IRML), which contain various beneficial ingredients such as ceramides in formulations designed to be well tolerated by individuals with eczema.

MATERIALS AND METHODS

This was a 4-week, single center, randomized, double-blind, split-body study that consisted of the application of Eczema Soothing Moisturizer (Cetaphil® Eczema Restoraderm Soothing Moisturizer, Galderma, Dallas, TX) versus Itch Relief Moisturizing Lotion (CeraVe® Itch Relief Moisturizing Lotion, L'Oreal Active Cosmetics Group, Paris, France). Participants were randomized to apply ESM to the arm/leg on one side and IRML to the other side twice daily, with test sites at the volar forearms and outer lower legs. The study was conducted according to Good Clinical Practice. All participants provided written informed consent prior to the study start.

Patients were eligible to participate if they were healthy adults and had self-perceived mild-to-moderate eczema-prone skin characterized by dryness, itchiness, and flakiness. In addition, they had dry skin determined by test sites on the forearm and leg with corneometer measurement <30 au (arbitrary unit) at baseline. Patients were excluded if they had active flaring disease, damaged skin at test sites, a recent skin rash, recently treated skin cancer, or were using immunosuppressive therapy and/or undergoing radiation treatments. All participants agreed to discontinue use of current skincare products (cleansers, lotions, sunscreens) for the duration of the study.

Participants agreed to the following washout periods: 3 days for skincare products; 1 week prior to baseline for anti-inflammatory or antihistamine medications; 2 weeks for acne treatment and topical corticosteroids; 4 weeks for oral corticosteroids, oral antibiotics, and immunosuppressants; and 6 months for oral isotretinoin.


Efficacy assessments included corneometer (Courage and Khazaka, Germany), evaporimeter (Cortex Technology, Hadsund, Denmark), and D-squame® tape stripping (CuDerm® Corporation, Dallas, Texas) at baseline and week 4. Ceramide analysis from the tape strips was analyzed at QIMA Synelvia (Labege, France). In addition, photography was performed on a subgroup of 10 participants. A questionnaire on product attributes, improvements, and overall preference was self-administered at weeks 1 and 4 of treatment. Safety was assessed by collection of adverse events, and evaluation of local skin tolerability.