Individual Article: Evaluation of Efficacy and Tolerability of Two Over-the-Counter Eczema Itch Relief Products

October 2023 | Volume 22 | Issue 10 | SF388641s10 | Copyright © October 2023


Published online September 30, 2023

Ahmed Hawash PhDa, Thu Nguyen PhDb, Ana Mantilla DPMb, Christine Emesiani PharmDb, Matthew Meckfessel PhDb

aUniversity of Miami, Miller School of Medicine, Miami, FL 
bGalderma Laboratories, L.P., Dallas, TX

Abstract
Background: Study to compare efficacy, tolerability, and patient perception between an over-the-counter itch relief gel (IRG) and itch relief moisturizing cream (IRMC) after a single application. 
Methods: Single-center, randomized, blinded, split-body study comparing IRG vs IRMC in adults with eczema-prone skin and mild-to-moderate itch. Assessments included itch relief duration upon application, itch severity (0=none to 9=severe at baseline [BL], 8, 12, and 24 hours), tolerability (0=none to 3=severe), and self-assessment questionnaire about product attributes and preference. 
Results: Thirty-three females and males with a mean age of 49.7 completed the study. Average time to itch relief was 28.5 seconds for IRG vs 41.8 for IRMC (P<0.05), with first onset at 5 seconds. In the IRG group, itch severity was reduced from 4.4 at BL to 1.4 at 8 hours; in comparison, itch was reduced from 4.4 at BL to 2.6 at 8 hours in the IRMC group (P<0.05). Both products significantly relieved itch vs baseline at all time points. IRG had better tolerability, with burning/stinging going from 1.5 at BL to 0.8 at 24 hours vs 1.5 at BL to 1.2 at 24 hours for IRMC (P<0.05). There was a trend in favor of IRG vs IRMC on the patient satisfaction self-assessment questionnaire.
Conclusions: IRG provided rapid itch relief and significantly outperformed IRMC. Both products significantly improved itch severity for up to 24 hours after application, with IRG outperforming IRMC at 8 hours. Additionally, IRG moderated stinging/burning sensations better than IRMC. Further, IRG was preferred by participants over IRMC.

J Drugs Dermatol. 2023;22:10(Suppl 2):s10-15.
 

INTRODUCTION

Eczema, also called atopic dermatitis, is an inflammatory skin disease characterized by skin barrier damage, which translates to itch, dry skin, rash, scaling, blisters, and skin 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.