HELPING YOUR PATIENTS WITH ATOPIC DERMATITIS

 

 

EpiCeram® Description

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.

 

 

 

 

EpiCeram® maintains a healthy skin barrier that goes beyond moisturizing

 

 

EpiCeram® maintains a healthy skin barrier that goes beyond moisturizing

 

  • Only topical treatment for atopic dermatitis formulated with the three essential physiological lipids in a patented 3:1:1 ratio
  • Ceramide dominant delivering the highest ceramide level of Rx topical agents
  • Only EpiCeram® utilizes the patented MultiSalTM release technology—a dual encapsulation system that allows for sustained delivery and enhanced absorption.
  • Steroid free
  • Can be used by patients of all ages with no restrictions on use on the face or in skin folds.

 

EpiCeram® Nourishes the Skin Environment to Benefit the Healing Process in Patients with Atopic Dermatitis

 

The unique MultiSalTM 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.

 

 

 

Indications for Use

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.

 

Warnings

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.

 

Contraindications

EpiCeram® Controlled Release Skin Barrier Emulsion is contraindicated in persons with known hypersensitivity to any of the components of the formulation.

 

EpiCeram® is a Prescription Device.

 

 

EpiCeram® uses MultiSalTM Encapsulation Technology that allows the release of different functional ingredients at the same location, but at different times.1

 

Before and After Photos

 

 

Moderately severe subacute atopic dermatitis of the antecubital fossae

 

Photos courtesy of Joseph Bikowski, MD.
Case report photos are reflective of one patient’s results and were not a part of a study.*

 

Clinical Studies

Clinical Study: EpiCeram® compared to fluticasone (Cutivate)†

In a 5-center randomized trial in 121 pediatric patients, EpiCeram® was compared to fluticasone 3

 

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, Cutivate®cream). 3

 

Primary outcome measures were: Reduction in disease severity assessed by SCORAD, improvement in pruritus (itch); and improvement in sleep habits.*

 

EpiCeram® reduced clinical disease severity, decreased pruritus and improved sleep habits 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 and sleep habit scores were comparable and not statistically significantly different at Day 14 and 28.

 

 

SCORAD scores for EpiCeram® treated patients decreased 37% and 51% from baseline at 14 and 28 days respectively.

 

No severe adverse events attributable to these agents occurred in either group. Four out of 59 patients in the EpiCeram®group required “short-term” fluticasone therapy. All 4 patients were considered rebound flares. 3

 

In Pediatric Patients: EpiCeram® has proven efficacy for the management of the symptoms of atopic dermatitis.

 

 

* EpiCeram® is not a sleep inducing agent or sleep aid. Reduction in sleep difficulty related to reduction in AD symptoms.

 

 

“These results suggest that [EpiCeram®] when used as monotherapy can significantly reduce the need for the use of topical steroids for many pediatric patients with moderate-to-severe atopic dermatitis.”3
— Jeffrey L. Sugarman MD PhD*

 

Clinical Study: Open Label Experience Trial

EpiCeram® Offers Real World Flexibility in Managing The Common Symptoms of Atopic Dermatitis

Effective as monotherapy in mild-to-moderate disease4

 

In an open-label study of two hundred and seven pediatric and adult patients with mild to moderate atopic dermatitis, EpiCeram® was applied to affected areas for 3 weeks.2 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.4

 

 

No serious adverse events were reported. Six subjects reported a total of 7 related, mild or moderate adverse events. An additional nine subjects reported worsening of AD that was considered an AE.

 

† Cutivate is a registered trademark of PharmaDerm.

References:

  1. 1. Data on File. 20 Kingsbridge Rd Piscataway, NJ: PuraCap® Pharmaceutical, LLC; 2008.
  2. 2. Bikowski J. Understanding the Structure, Function, and Strategies for Repair of the Epidermal Barrier.
    Practical Dermatology. 2009 May:17-18.
  3. 3. 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.
  4. 4. Kircik LH, Del Rosso JQ. Evaluating Clinical Use of a Ceramide-Dominant, Physiologic Lipid-based Topical Emulsion for Atopic Dermatitis. J of Clinical Aesthetic Derm. 2011;4(3):34-40.