EpiCeram® contains the ingredients to help restore the skin barrier in patients with atopic dermatitis and other type of dermatosis

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EpiCeram Helps Maintain a Healthy Skin Barrier That Goes Beyond Moisturizing


EpiCeram helps repair and heal the skin barrier through a unique delivery system not found in other products. EpiCeram contains 3 essential lipids– ceramides, conjugated linoleic acid (CLA), and cholesterol — in a physiologically balanced patented 3:1:1 ratio, which are reduced in patients with eczema and atopic dermatitis. EpiCeram is steroid-free, fragrance-free, noncomedogenic, paraben-free, and propylene glycol-free.



Help to repair the Skin Barrier with EpiCeram



EpiCeram with Patented MultiSal™ Technology Allows for High-Lipid Deposition and Absorption Over Time


The MultiSal Encapsulation Delivery Technology is based on a unique proprietary system consisting of multi-component microspheres that contain submicron spheres. These submicron spheres are infused with the physiological lipid in an active form. Rubbing the emulsion onto the skin triggers this two-step delivery system. Once the microsphere is broken, the submicron spheres gradually deliver the physiological lipids over time. The special microsphere structure stabilizes the lipids from premature oxidation.



Real-World Cases
Before & After Treatment with EpiCeram




Adult Patient (Age 58, Female)


Before

Dx: Atopic dermatitis, dry skin, eczema
Rx: EpiCeram applied BID to all affected areas

After 2 Weeks

90% reduction in the erythema, dryness, and scaling of the antecubital fossa bilaterally


Child Patient (Age 14, Male)


Before

Painful fissures located on distal tip of the left thumb, as well as the right middle finger
EpiCeram applied BID for 2 weeks

After 2 Weeks

Cracked, fissuring fingertips showed dramatic improvement in 48 hours
Completely pain and fissure free at this time


Adolescent Patient (Age 17, Male)


Before

Severe Xerosis Secondary to Isotretinoin Use
- Used many OTC moisturizers TID with worsening xerosis
Rx: EpiCeram minimum BID and can apply as needed throughout the day

After 4 Weeks

Xerosis fully resolved
Continue to apply EpiCeram as needed throughout the day
Continue with normal cleansing routine


References:
1. Bikowski J. Understanding the Structure, Function, and Strategies for Repair of the Epidermal Barrier. Practical Dermatology. 2009; May: 17-18
2. Data on File. Primus Pharmaceuticals, Inc.
3. EpiCeram [package insert]. Scottsdale, AZ. Primus Pharmaceuticals Inc; 2018.



Clinical Studies


Efficacy of EpiCeram in Moderate-to-Severe Atopic Dermatitis Pediatric Patients

In pediatric patients with moderate-to-severe AD, EpiCeram demonstrated efficacy at day 28 similar to a mid-potency steroid



In a prospective investigator blinded randomized trial of 121 pediatric patients with moderate-to severe atopic dermatitis, EpiCeram used as monotherapy demonstrated efficacy comparable to a mid-potency topical steroid fluticasone 0.05% cream.

Primary endpoints:

EpiCeram reduced clinical disease severity, decreased pruritus both at the 14 and 28 day assessment points. Although the fluticasone treated group showed significantly greater improvement in SCORAD score at 14 days, EpiCeram did not differ significantly at 28 days. Improvement of pruritus scores were comparable and not statistically significantly different at Day 14 and 28.


EpiCeram demonstrated comparable efficacy to fluticasone in moderate to severe AD (Based upon changes in SCORAD scores)


EpiCeram reduced pruritus by 52%


No severe adverse events attributable to these agents occurred in either group. 4 out of 59 patients in the EpiCeram group required “short-term” fluticasone therapy. All four patients were considered rebound flares.


References:
1. Sugarman JL, Parish LC. Efficacy of a lipid-based barrier repair formulation in moderate-to-severe pediatric atopic dermatitis. J Drugs Dermatol. 2009;8(12): 1106-1111

Clinical Study: Evaluating Clinical Use of EpiCeram for Atopic Dermatitis


EpiCeram can be used as monotherapy or in combination in mild to moderate AD patients with no age restriction


In an open-label study of 207 pediatric and adult patients with mild to moderate atopic dermatitis, EpiCeram was applied to affected areas for 3 weeks. Subjects were also given a prescription for another atopic dermatitis medication and instructed to use this medication along with the EpiCeram as combination therapy, only if their condition worsened.




54% of all subjects experienced treatment success (clear or almost clear) at week 3, based on the Investigator’s Global Assessment (IGA)

There were no serious Adverse Events (AE). Only 3% reported mild to moderate AE including worsening of atopic dermatitis, erythema, skin irritation, pruritis, paresthesia, and pain

EpiCeram demonstrated to be effective in initial management of AD and may be sufficient in monotherapy in mild to moderate patients
References:
1. Kircik LH, Derl Rosso JQ, Aversa D. Evaluation Clinical use of a ceramide-dominant, physiologic lipid-based topical emulsion for atopic dermatitis. Journal of Clinical and Aesthetic Dermatology. March 2011; 4 (3): 34-40

Frequently Asked Questions

EpiCeram Control Release Skin Barrier Emulsion is a unique, prescription only, topical skin-barrier repair product developed for the treatment of atopic dermatitis. EpiCeram contains 3 essential lipids– ceramides, conjugated linoleic acid (CLA), and cholesterol in a physiologically balanced patented 3:1:1 ratio. Uniquely formulated to address skin barrier function, EpiCeram is also steroid-free, fragrance free, non-comedogenic, 1 paraben-free, and propylene glycol-free.

Purified Water, MultiSal™ Neolipids*, Glyceryl Stearate, Squalane, Glycerin, PEG-100 Stearate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Petrolatum, Dimethicone, Phenoxyethanol, Cholesterol, Conjugated Linoleic Acid, Citric Acid, Palmitic Acid, Xanthan Gum, Potassium Hydroxide, Disodium EDTA, Sorbic Acid, Capric Acid.

*Proprietary microencapsulation system for gradual delivery of key ingredients including Ceramide, CLA, Cholesterol and Palmitic Acid (Formulated with E.Cerifera (Candelilla) wax, corn syrup solids, and modified food starch).

EpiCeram Controlled Release Skin Barrier Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. EpiCeram helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

EpiCeram creates a skin environment beneficial to the healing process in patients with Atopic Dermatitis. The MultiSal Encapsulation Delivery Technology is based on a unique proprietary system consisting of multi-component microspheres that contain submicron spheres. These submicron spheres are infused with the physiological lipid in an active form. Rubbing the emulsion onto the skin triggers this two-step delivery system. Once the microsphere is broken the submicron spheres gradually release the lipids over time. The special microsphere structure stabilizes the lipids from premature oxidation, maintaining the integrity of the product.
EpiCeram® [package insert]. Scottsdale, AZ. Primus Pharmaceuticals Inc; 2018.

Administration of EpiCeram involves applying a thin layer to the affected skin two times per day (or as needed) and massaging it gently into the skin. If there are breaks in the skin, the affected area should be covered with a dressing of choice after treatment.

EpiCeram Controlled Release Skin Barrier Emulsion is an atopic dermatitis treatment that aims to assist in the repair of the skin barrier abnormalities in atopic dermatitis. In this way, EpiCeram differs from other products such as corticosteroids and topical immunomodulators because it targets the outside-in model of atopic dermatitis pathophysiology.

EpiCeram can be used on adults and children; there are no age restrictions on the use of EpiCeram Controlled Release Skin Barrier Emulsion.

Yes, EpiCeram can be used on the face and skin folds. There is no age or location restrictions for EpiCeram.

In a prospective, non-controlled study conducted in patients with mild-to-moderate atopic dermatitis, EpiCeram demonstrated symptomatic relief when used in combination with other available therapies, such as corticosteroids and topical immunomodulators, in some patients.

EpiCeram is a prescription-only medical device cleared by the FDA and is available through retail pharmacies or through Primus Care Direct. Primus Care Direct is a hassle-free, mail-order pharmacy that guarantees patients will pay the lowest possible price on their EpiCeram prescription.

EpiCeram is a FDA-cleared prescription medical device. EpiCeram has demonstrated efficacy in several atopic dermatitis clinical studies with more than 300 patients. It can be used in patients with mild to severe atopic dermatitis.

EpiCeram is contraindicated in persons with known hypersensitivity to any of the components of the formulation.

EpiCeram Controlled Release Skin Barrier Emulsion does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas. In radiation dermatitis and/or in conjunction with ongoing radiation therapy apply following radiation therapy. Do not apply within 4 hours prior to radiation therapy. Apply twice daily or as indicated by the radiation therapist. After application, a temporary tingling sensation may occur (10 to 15 minutes). Keep this and similar products out of the reach of children. Follow directions for use. If condition does not improve within 10 to 14 days, consult a physician.

Following the application of EpiCeram a temporary tingling sensation may occur (10-15 minutes).

EpiCeram Controlled Release Skin Barrier Emulsion is available in a 90g tube and a 225g airless pump.

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