SOURCE: Graceway Pharmaceuticals

September 10, 2008 16:00 ET

Itching for Fall: Eczema Season Is Here

BRISTOL, TN--(Marketwire - September 10, 2008) - Fall has arrived, and for one in five children, that means it is eczema season. Eczema, also known as atopic dermatitis (AD), is a chronic skin condition that causes itching, rash, scaliness, redness, inflammation, weeping and crusting of the skin.

"Atopic dermatitis can occur at any time of year, and for some patients, unfortunately, it is a year-round problem," said Dr. Mark Boguniewicz, pediatric allergist-immunologist at the National Jewish Medical and Research Center in Denver, Colorado. "However, for most patients, it is typically worse in the cold, dry months of fall and winter."

This condition appears most frequently on the hands and face, and one of the biggest challenges is dealing with the intense itching. Itch is especially troubling for infants and children, who become irritable and uncomfortable.

According to Dr. Boguniewicz, "Atopic dermatitis is much more than an itchy rash. These children often scratch to the point of bleeding. Their itching interferes with other activities, most importantly sleep."

AD flare-ups are usually treated with topical steroid creams, but many parents are concerned about using steroids on their children for extended periods.(1) A recently published study in the June issue of The Journal of Pediatrics showed that Atopiclair® nonsteroidal cream is safe and effective as a monotherapy for the treatment of symptoms of mild to moderate atopic dermatitis in infants and children.(2)

"This study shows that Atopiclair improves the symptoms and appearance of eczema in children and infants. The fast improvement in itch will be particularly important to patients and their families. Steroid-sparing therapies are especially useful when treating children with this chronic, relapsing condition and so we were pleased that patients using Atopiclair in this study had significantly less need for steroid creams," said Dr. Boguniewicz, the lead investigator of the study.

The 43-day study was conducted in multiple US centers, and involved 142 patients (age 6 months to 12 years), treated 3 times a day with either Atopiclair or vehicle base cream. Rapid resolution of itch was demonstrated by a 37% improvement in mean itch score by day 3. Dramatic improvement in itch from baseline continued through the study in the Atopiclair group, reaching 78% by day 43. By day 22, investigators rated 77% of patients treated with Atopiclair as "clear" or "almost clear" of mild to moderate symptoms that were present on day 1.(2)

The most commonly reported adverse events in the study were stinging (8%), burning (7%), and fever (7%) in the Atopiclair group and upper respiratory infections (9%), burning (7%), fever (7%), and colds (7%) in the vehicle group.(1) The percentage of adverse events judged by investigators to be related to the study medication was 17% in the Atopiclair group and 13% in the vehicle group. Adverse events led to discontinuation in 10% of those treated with Atopiclair and 16% of those treated with vehicle.

About Atopic Dermatitis

Approximately 17% of school-aged children in the United States have AD, a chronically relapsing skin disorder.(3) AD is characterized by a number of complex skin abnormalities and its management commonly requires numerous treatment modalities.(2) Symptoms and sleep disruptions caused by the disease can negatively impact quality of life for patients and their families.

About Atopiclair

Atopiclair Nonsteroidal Cream is available by prescription only. Atopiclair contains powerful moisturizers and key lipids that help maintain a healthy skin barrier while providing relief of itching and other symptoms associated with AD. Atopiclair has no restriction on duration of use and has been studied in children as young as 1 month of age.(4) Atopiclair provides physicians with a much needed, steroid-free option for the long-term treatment of AD, alone or in combination with other therapies. Atopiclair may be particularly useful in pediatric patients because they may face increased risk of adverse events associated with steroids.(5)

Under the supervision of a health care professional, Atopiclair nonsteroidal cream is indicated to manage and relieve the itching, burning, and pain experienced with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. Atopiclair nonsteroidal cream helps to relieve dry, waxy skin by maintaining a moist skin environment, which is beneficial to the healing process.

Atopiclair nonsteroidal cream does not contain milk, wheat, peanut or animal derivatives. Atopiclair nonsteroidal cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation. For external use only; avoid contact with eyes.

Atopiclair is manufactured under license from Sinclair Pharmaceuticals Ltd. Please visit to request additional information, including the full US Prescribing Information.

About Graceway Pharmaceuticals, LLC

Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN, is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Current prescription products marketed by Graceway include Aldara® (imiquimod) Cream, 5%, Maxair® Autohaler® (pirbuterol acetate inhalation aerosol), Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical emulsion). Aldara®, Maxair® Autohaler®, Atopiclair®and Estrasorb® are trademarks owned by or licensed to Graceway. For more information on Graceway's products, including Important Safety Information, please visit To download video in seven formats please visit


(1.) Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol. 2006;118(1):226-232.

(2.) Boguniewicz M, Zeichner JA, Eichenfield LF, et al. MAS063DP is effective monotherapy for mild to moderate atopic dermatitis in infants and children: a multicenter, randomized, vehicle-controlled study. J Pediatr. 2008;152(6):854-859.

(3.) Laughter D, Istvan JA, Tofte SJ, Hanifin JM. The prevalence of atopic dermatitis in Oregon schoolchildren. J Am Acad Dermatol. 2000;43(4):649-655.

(4.) Data on file. Graceway Pharmaceuticals, LLC.

(5.) Callen J, Chamlin S, Eichenfield LF, et al. A systematic review of the safety of topical therapies for atopic dermatitis. Br J Dermatol. 2007;156(2):203-221.

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