Individual Article: A Novel 3-Step Over-the-Counter Eczema Regimen Improves Eczema Severity, Itch, and Life Quality: Randomized Study
October 2023 | Volume 22 | Issue 10 | SF388641s21 | Copyright © October 2023
Published online September 30, 2023
Kristi Hawley DO FAADa, Peter Lio MDb, Thu Nguyen PhDc, Aamir Qureshi MDc, Christine Emesiani PharmDc, Matthew Meckfessel PhDc
aThe Derm Institute of West Michigan; Michigan State University College of Osteopathic Medicine, Petoskey, MI
bMedical Dermatology Associates of Chicago, Chicago, IL
cGalderma Laboratories, L.P., Dallas, TX
Abstract
Background: Eczema, or atopic dermatitis (AD), is a chronic relapsing skin disease associated with unpredictable flares of erythema, rash, and pruritus. AD arises from a combination of immune system dysregulation and abnormal skin barrier function. Skin barrier support with proper skincare regimens have a central role in management.
Methods: This was a multi-center, 12-week in-use study of a skincare regimen in children and adults with mild-to-moderate eczema (6-16) on the Patient-Oriented Eczema Measure (POEM), and ≥2 flares within 3 months prior to screening. The regimen included Itch Relief Gel, Eczema Soothing Lotion, and Flare Relief Cream. Efficacy assessments included POEM, ItchyQuant, Eczema Area and Severity Index (EASI), Quality of Life and digital photography, along with gathering of adverse events and cutaneous tolerability.
Results: 34 subjects completed the study. In 12 weeks, mean POEM scores improved from 9.7 to 5.3, and EASI scores improved by 17.9% (P<0.05 vs baseline). Additionally, mean ItchyQuant scores showed that pruritus was significantly improved from 5.4 at baseline to 2.7 at week 12 (P<0.05). The number of flares decreased from 4.2 to 3.2 after 12 weeks of regimen application (P<0.05 vs 12 weeks before baseline). Quality-of-life measures also showed improvement in both children and adults from baseline (P<0.05). There were no related adverse events, the regimen was well tolerated, and participants had positive perceptions of the regimen.
Conclusions: 12-week use of this OTC skincare regimen resulted in significant improvements in EASI, POEM, and ItchyQuant scores, a reduced number of flares, and improved quality of life.
J Drugs Dermatol. 2023;22:10(Suppl 2):s21-26.
INTRODUCTION
Eczema, or atopic dermatitis (AD), is a common skin condition which is estimated to affect >31 million people in United States, with up to 25% of children and almost 10% of adults diagnosed at least one time with the disease.1,2 It is characterized by recurrent, unpredictable flares of dryness, itchiness, scaling, roughness, irritation, and/or discoloration.3 Classic AD is often associated with skin distribution patterns: AD tends to affect flexural areas, but the hands and feet can also be involved, especially in adults.3 Non-classic forms also exist, which can complicate the picture. Eczema is frequently associated with a negative impact on quality of life (QoL) and sleep loss due to itch.2,3 Indeed, sleep disruption and fatigue are primarily responsible for poor QoL in eczema, along with restricted activities and depression due to disease and chronic, intractable itch.3 Further, it has been shown that the effect of eczema on QoL is not limited to the sufferer - rather, oftentimes caregivers and parents also have reduced life quality.3 The family members report having sleep problems and fatigue, treatment-related costs, and negative feelings surrounding the disease. As an example, Moore et al found that depression is twice as common in mothers of children with eczema compared to mothers of children with asthma.4 Beyond the humanistic burden, eczema also imposes an economic burden on patients and families.5 A 2023 study found that pediatric patients with eczema have a mean yearly cost of $3,279, with variations among the countries studied (range: $1,540 to $7,943).5 Both direct and indirect costs incurred by patients and families increase with eczema severity, with the highest costs associated with biologic treatments.5
