week 4, participants reported improved comfort (82.4%), soothed skin (82.4%), and overall improvement (79.4%). By week 8, patient responses indicated improvements in rough scaly areas (88.2%), eczema symptom relief and less worry (73.5%), visible improvement (76.5%), and healthier looking skin (73.5%). At the last study visit at week 12, participants reported increased confidence (76.5%), better overall comfort (79.4%), and that the regimen had helped their eczema skin (82.4%). In addition, a significantly greater proportion of participants indicated they would recommend/purchase the regimen.
Safety
A total of 4 adverse events were reported, and none were judged by investigators to be related to study treatment (sprained ankle, removal of surgical hardware, seasonal allergy, and COVID-19). All were mild-moderate in severity. The skincare regimen was well-tolerated with no worsening in subjective tolerability at any post-baseline study timepoint (Figure 5). For those with eczema-affected areas of the face, each patient scored burning/stinging on the overall face and periocular area as 0 at all study visits.
DISCUSSION
Twelve-week treatment with the skincare regimen resulted in significant improvements in eczema severity (shown by reductions in EASI and POEM scores) as well as reduced itch severity and number of flares. Consequently, QoL for participants improved to a clinically relevant degree. There was no worsening or significant increase in tolerability grading and no adverse events judged to be related to the regimen. Further, the skincare regimen was well received by study participants.
Maintaining a healthy skin barrier, controlling itch, and managing exposure to triggers are 3 primary components of eczema management, along with good patient and family education.3 Since good skin care provides the foundation of eczema management, patients and parents should be educated about how to develop good skincare habits and the importance of using skin care daily.3,9 Frequent moisturizing relieves discomfort associated with dry skin, contributes to skin barrier repair, and reduces the need for pharmacologic interventions.10,11 Miller et al demonstrated that OTC moisturizers are as effective and less expensive than prescription creams for children with mild-to-moderate eczema.12 In addition, studies have reported that steroid phobias are not uncommon in both patients and families of children with eczema.13,14 Regular use of eczema-appropriate moisturizers helps to decrease use of moderate or potent topical corticosteroids while improving eczema symptoms.9
The 3-step skincare regimen incorporates a wide range of key active ingredients to address the symptomatology of eczema. These include colloidal oatmeal to protect skin, filaggrin, and ceramides to help strengthen the skin barrier, and moisturizing and emollient ingredients1 to soothe the skin. The regimen does not have parabens, steroids, propylene glycol, or fragrances, which is ideal for eczema-prone skin.3 In recent years, it has become accepted that filaggrin has a major role in maintaining the structure and formation of the stratum corneum.3,8,15 A recent systematic review reported that colloidal oatmeal was associated with statistically significant improvements in skin thickness, dryness, and itching.16 Colloidal oatmeal is recognized by the US Food and Drug Administration as a monograph OTC skin protectant for the management of eczema skin. In 2022, Larese Filon et al found that regular use of a cream that included ceramides achieved significantly better clinical outcomes in hand eczema compared with creams that did not include ceramides.17 These data show that the specific ingredients in an eczema regimen can translate to clinical differences.
Our study demonstrated this eczema skincare regimen was suitable for an inclusive range of ages, genders, skin tones, and races/ethnicities. Epidemiologic studies indicate that eczema is most
