EpiCeram Skin Barrier Emulsion for the Treatment of Mild-to-Moderate Atopic Dermatitis - A Pilot Study

 

INTRODUCTION

EpiCeram® Skin Barrier Emulsion is a new FDA-cleared mixture of the three stratum corneum lipids, with ceramide as the dominant species, as topical therapy for atopic dermatitis (AD). EpiCerama is also used to manage the burning and itching associated with various other dermatoses, including irritant contact dermatitis and radiation dermatitis. This emulsion was designed to correct epidermal barrier dysfunction and to reduce inflammation in various inflammatory dermatoses.
 
Product Description
Epiceram® Controlled Release Skin Barrier Emulsion is a steroid free, fragrance free ceramide dominant emulsion containing ceramide, conjugated linoleic acid (CLA), and cholesterol in an emollient base. These physiological lipids are delivered via a patented time-release system to insure a physiological level over time and maximal performance. The 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 and optimal configuration. 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 yielding a product at its highest efficacy.

 

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. EpiCeram® helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

 

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

 

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. 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.

 

Precautions and Observations
For the treatment of any dermal wound, consult a physician.
– Use EpiCeram® Controlled Release Skin Barrier Emulsion only as directed.
– EpiCeram® is non-toxic, however it is for external use only and should not be ingested or taken internally.
– If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of EpiCeram® may be continued during the anti-infective therapy.

– If the condition does not improve within 10-14 days, consult a physician.
– EpiCeram® 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.
– Following the application of EpiCeram®, a temporary tingling sensation may occur (10-15 minutes).
– Keep this and similar products out of the reach of children.

 

Instructions for Use
Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. If the skin is broken, cover EpiCeram® Controlled Release Skin Barrier Emulsion with a dressing of choice.

 

Ingredients
Purified Water, MultiSalTM 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).

 

How Supplied
EpiCeram® Controlled Release Skin Barrier Emulsion is supplied as follows:
NDC 51013-800-90: 90 gram tube
NDC 51013-800-36: 225 gram airless pump
 
Store at 15°C to 30°C (59°F to 86°F). Do not freeze
EpiCeram® is a registered trademark of PuraCap® Pharmaceutical LLC, South Plainfield, NJ 07080
MultiSalTM is a trademark of Salvona Technologies LLC.
Made in the USA
Distributed by: PuraCap® Pharmaceutical LLC, South Plainfield, NJ 07080
www.EpiCeram-US.com
 
U.S. Patent No. 5,643,899.
U.S. Patent No. 6,979,440.
U.S. Patent No. 7,115,282.
 

OBJECTIVE

An investigator-blinded comparison of the safety and efficacy of EpiCerama for the treatment of mild-to-moderate pediatric AD with standard nonsteroidal therapy, Elidela Cream (pimecrolimus 1%).

 

STUDY DESIGN

Study Treatmen :

- EpiCeram Skin Barrier Emulsion or Elidel Cream (pimecrolimus 1%) to active areas of AD only- Twice daily for 4 weeks- Cetaphil Cream for areas of xerosis- Rescue treatment, if necessary (=1 wk of triamcinolone 0.1% ointment)

 

Subject Population :

- 38 subjects enrolled- 2-12 years old- Mean age 6 years old- Mild-to-moderate disease (Rajka-Langeland Severity Index)- Specified washout period (1 week for topicals)

 

Methods :

- Randomized-equal numbers per group- Parallel Groups- 2 Sites- IRB-approved protocols- Parental informed consent

 

Assessments :

- Baseline, Week 2, and Week 4- EASI Score - 0 to 72 (Eczema Area and Severity Index)- IGA (Investigator Global Assessment) - 0=clear, 1=almost clear, 2-mild, 3=moderate, 4=severe, 5=very severe- Pruritus Severity - visual analog scale 0 to 10

 

RESULTS

- Statistically significant difference in median EASI score reduction at week 2 between groups but none at week 4 (Figure 1A).- No statistically significant differences in the proportion of subjects with either >50% improvement in EASI score or >75% improvement in EASI scores between groups at week 4 (Figure 1B).- Statistically significant reduction (p<0.05) from baseline in IGA mean scores at weeks 2 and 4 for both treatments (Figure 2A).- Statistically significant difference in IGA mean score between treatments at week 2 (Figure 2A).- No statistically significant difference between treatments in proportion of subjects with IGA success (clear or almost clear) at week 4 (Figures 2B and 2C).- No statistically significant difference between treatments for pruritus mean scores at weeks 2 or 4. The majority of subjects had low levels of pruritus during the study (Figures 3A and 3B).

 

TABLE 2. NUMBER OF ADVERSE EVENTS