EpiCeram Skin Barrier Emulsion: Clinically effective first-line treatment for atopic dermatitis
EpiCeram® Skin Barrier Emulsion is the only prescription product that delivers an optimal 3:1:1 ratio of ceramides, cholesterol, and free fatty acids shown to help repair a damaged skin barrier in atopic patients of all ages. Please stay tuned for an important message from Promius Pharma about how EpiCeram Skin Barrier Emulsion offers your patients the efficacy of a midpotent topical steroid at day 28 without the associated long-term risks for effective first-line treatment of atopic dermatitis.
The current first-line topical therapy for atopic dermatitis in children and adults is topical steroids. Topical steroids have been utilized for over 50 years to treat the inflammation and itch associated with atopic dermatitis. Although effective, topical steroids have the potential for adverse events with long-term use or large body area application. There are also usage restrictions on body areas, patient age, and duration of treatment. There is now another choice that has demonstrated comparable efficacy to a midpotent topical steroid without the associated long-term side effects.
EpiCeram Skin Barrier Emulsion is a novel prescription product for the first-line treatment of atopic dermatitis. EpiCeram delivers comparable efficacy to a midpotent steroid without the associated long-term risks. In clinical studies, there was no statistical difference between EpiCeram and fluticasone propionate 0.05% cream in reducing the signs and symptoms of atopic dermatitis after 28 days of treatment. EpiCeram has an excellent safety profile. And, EpiCeram can be used on all age groups, without any restriction on face or intertriginous area application.
Recent research has suggested that a genetic abnormality in atopic patients leads to a dysfunctional skin barrier and not an abnormal immune system, as the primary cause of atopic dermatitis. This “outside-in” theory of atopic dermatitis is based on an emerging consensus that a barrier defect is the primary driver of atopic dermatitis. This structural defect in the skin barrier results in increased transepidermal water loss or TEWL, increased exposure to allergens and pathogens, and secretion of inflammatory cytokines in the epidermis. This chronically defective skin barrier leads to a cascade of events that ultimately ends in the typical signs and symptoms of atopic dermatitis, including inflammation, itching and dryness. Under this “outside-in” theory, barrier normalization therapies act at the initial step in the pathogenesis of atopic dermatitis. Anti-inflammatory agents work downstream of the skin barrier defect.
The structure and function of the stratum corneum is crucial to understanding the outside-in theory of atopic dermatitis. Viewed as the “brick and mortar” model, the functions of the stratum corneum can be ascribed to the corneocytes (bricks) and the lipid bilayers (mortar). The corneocytes create a physical antimicrobial and UV protection barrier. Corneocytes also regulate skin hydration by attracting water. The lipid bilayers, made of ceramides, cholesterol, and free fatty acids, create a barrier that excludes external material and prevents water loss. Failure in either of these structures can lead to loss of function that may contribute to the pathogenesis of atopic dermatitis.
To determine the most effective barrier normalization therapy, various ratios of ceramides, cholesterol, and free fatty acids underwent laboratory testing in mice to determine an optimal formulation. A 3:1:1 ratio of ceramides, cholesterol, and free fatty acids was shown to be an ideal combination for barrier repair based on the percent recovery of TEWL. Ratios outside of the 3:1:1 were not as effective in mice in reducing TEWL. EpiCeram Skin Barrier Emulsion is the only product to deliver an optimal 3:1:1 ratio of ceramides, cholesterol, and free fatty acids.
The efficacy of EpiCeram Skin Barrier Emulsion was validated in an investigator-blinded clinical trial of 121 patients diagnosed with moderate atopic dermatitis. During this clinical trial, EpiCeram was compared to fluticasone propionate 0.05% cream, when used twice daily for 4 weeks.
The primary efficacy endpoint of the clinical trial was reduction in SCORAD after 28 days of treatment. The results of the trial demonstrated that there was no statistically significant difference between EpiCeram and fluticasone propionate 0.05% after 28 days of treatment.
The secondary efficacy endpoints were pruritus and sleep disturbance. EpiCeram had comparable efficacy to fluticasone propionate 0.05% in reducing pruritus scores and sleep disturbance scores from baseline. At day 28, there was no statistically significant difference between groups.
The investigators of the clinical trial concluded that EpiCeram Skin Barrier Emulsion represents an effective first-line treatment and a potential adjunct therapy for mild to moderate atopic dermatitis.
EpiCeram® Skin Barrier Emulsion has five proposed mechanisms of action that work to reduce the signs and symptoms of atopic dermatitis:
- Bulk replenishment of physiologic lipids
- Enrichment of ceramides
- Delivery of an optimal 3:1:1 ratio of ceramides, cholesterol, and free fatty acids
- Creation of a vapor-permeable barrier
- Normalization of skin pH
EpiCeram not only replenishes the total lipid content, it also delivers the right type of lipids required for barrier repair—ceramides, cholesterol, and free fatty acids.
Patients with atopic dermatitis have low ceramide content in their skin. EpiCeram is a ceramide-dominant formulation that addresses this deficiency through enrichment.
EpiCeram delivers an optimal 3:1:1 ratio of ceramides, cholesterol, and free fatty. These physiologic lipids are thought to traverse the stratum corneum and become incorporated into the lamellar bodies of the stratum granulosum. In a small clinical study, the 3:1:1 ratio formulation increased the number of lipids within the skin barrier of patients with atopic dermatitis.
Occlusive dressings retard skin barrier normalization. In contrast, EpiCeram creates a vapor- permeable barrier that allows for skin barrier normalization.
Skin p-H is higher in people with atopic dermatitis. EpiCeram has a pH of approximately five, a level similar to normal skin. EpiCeram helps lower the pH of atopic patient skin. This benefit supports integrity of the stratum corneum, and the formation and maturation of the lipid lamellae.
No other topical atopic dermatitis treatment delivers an optimal 3:1:1 ratio shown to help repair a damaged atopic skin barrier. To learn more about how EpiCeram can help your atopic patients, click on the link at the end of this presentation to request more information or a visit from a representative.