SkinMedica Introduces Desonate(R) (desonide) Gel 0.05% TwinPack for Treatment of Mild to Moderate Atopic Dermatitis

January 8, 2008

CARLSBAD, Calif., Jan. 8 - SkinMedica, Inc., a specialty pharmaceutical company focused on dermatology, announced the availability of the Desonate (desonide) Gel 0.05% 120g TwinPack for the treatment of mild to moderate atopic dermatitis. Desonate is a low-potency prescription
topical steroid formulated in Dow Pharmaceutical Sciences’ proprietary water-based Hydrogel vehicle.

The new economical Desonate TwinPack contains two 60-gram tubes of Desonate Gel for greater coverage of affected areas during the cold-weather season when atopic dermatitis tends to flare most. With the Desonate TwinPack, patients have the added convenience of keeping their medication in two accessible locations. With one prescription, patients can receive twice as much therapy for the same pharmacy co-pay as the smaller tube.

“The Desonate TwinPack provides added value and flexibility to an already effective Desonate therapy,” said Dr. Rebecca Smith, Pediatric Dermatologist from a Charlotte, NC suburb. “I have many younger patients cared for by parents in more than one household, and having two tubes of Desonate allows both households to keep Desonate on hand when flares occur.
With the new TwinPack, Desonate with Hydrogel continues to provide effective therapy in a cosmetically acceptable, well tolerated formulation.”

Clinical studies with Desonate show significant reduction in itching and other symptoms of atopic dermatitis, and Desonate is clinically proven to moisturize and help skin maintain essential hydration by improving the skin barrier.

Additional Information about Desonate

As with other corticosteroids, therapy should be discontinued when control is achieved. Unless directed by a physician, the treated skin area should not be bandaged so as to be occlusive. Systemic absorption of topical corticosteroids, including Desonate Gel, has produced HPA axis
suppression, for which pediatric patients are more susceptible.

In clinical trials, the most frequent adverse events included headache (2%), application site burning (1%), rash (1%), and application site pruritus (<1%).>

About Desonate

Desonate is approved by the US Food and Drug Administration (FDA) for the treatment of mild to moderate atopic dermatitis in patients aged 3 months and older for up to 4 consecutive weeks. Formulated with desonide, the leading low-potency corticosteroid used in dermatology, Desonate is the first and only treatment for atopic dermatitis delivered via Hydrogel
technology. The versatile formulation can be used on small and large affected areas and is free of alcohol, fragrance, or surfactants that can be irritating or drying to the skin.

Desonate is jointly promoted by SkinMedica and Galderma Laboratories, L.P.

About Atopic Dermatitis

Atopic dermatitis affects more than 15 million patients, resulting in skin rash, redness, swelling, crusting, and scaling. The disease affects nearly 20% of infants and young children, some of which continue to experience symptoms as adults. The exact cause of atopic dermatitis is
unknown; however, genetics and environmental factors are considered key factors. Topical corticosteroids are the gold standard of treatment for atopic dermatitis, with more than $1 billion in prescriptions written annually by US physicians for inflammatory dermatoses.

For More Information on Desonate

For information about Desonate, including its approved labeling, please visit http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm or contact SkinMedica Customer Service at (877) 944-1412.

About SkinMedica

SkinMedica is a privately held pharmaceutical company marketing both prescription and aesthetic dermatology products. SkinMedica’s Desonate(R) (desonide) Gel 0.05% is indicated for the treatment of mild to moderate atopic dermatitis; EpiQuin(R) Micro (4% hydroquinone) cream is indicated for melasma and postinflammatory hyperpigmentation; VANIQA(R) (eflornithine hydrochloride) Cream, 13.9%, is the only FDA-approved prescription product
for the treatment of unwanted facial hair in women; and NeoBenz(R) Micro Cream and NeoBenz(R) Micro SD (single dose) are the only benzoyl peroxide prescription products that contain a patented gradual-release formulation of benzoyl peroxide to treat acne. The company’s full line of physician-dispensed skin care products includes TNS Recovery Complex(R) with NouriCel-MD(R) to help improve the health and appearance of aging
skin. SkinMedica is based in Carlsbad, California. For more information, visit http://www.skinmedica.com/.

Breast-Feeding Seems to Protect Against Some Allergies

It helps high-risk infants prone to eczema, asthma and food allergies, report suggests

By Amanda Gardner

Posted 1/7/08

MONDAY, Jan. 7 (HealthDay News) -- Atopic disease -- which includes eczema, asthma and food allergies -- may be delayed or even prevented in high-risk infants if they are exclusively breast-fed for at least four months or fed infant formula without cow milk protein.

That's the conclusion of a new clinical report from the American Academy of Pediatrics (AAP) that's published in the January issue of Pediatrics. The report replaces an earlier policy statement from the AAP.

"Basically, it probably does not matter what pregnant or lactating women eat," said Dr. Frank Greer, an author of the report, professor of pediatrics at the University of Wisconsin and chairman of the AAP Committee on Nutrition.

"The best prevention for atopic [allergic] disease is exclusive breast-feeding for four months," he added. "And if your infant comes from a family with significant atopic disease, then weaning from breast milk to a partially or extensively hydrolyzed [hypoallergenic] formula [without cow milk protein] may delay or prevent the onset of atopic disease, especially atopic dermatitis [eczema]."

Greer added that this recommendation would also apply to formula-fed infants who are at risk for atopic disease.

The timing and introduction of solid foods has no protective effect on the prevention of atopic disease, according to the new report.

"With the increase in asthma and food allergies that we've seen recently, we had hoped that maternal diet, breast-feeding and early childhood diet might all have some factor in decreasing incidence," said Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. "Unfortunately, it doesn't seem to significantly impact, according to studies already done. The only one that seems to be impacted is the atopic dermatitis, which is decreased by about one third by breast-feeding. But the studies that have been done so far have not proven that breast-feeding will significantly impact childhood asthma or food allergies."

The incidence of allergic diseases such as asthma, food allergies and various skin conditions has exploded during the past few decades. In children 4 years of age and younger, the incidence of asthma has risen 160 percent, while the incidence of atopic dermatitis has almost tripled. And the incidence of peanut allergy has doubled just during the past decade, according to the report.

While genetics certainly plays a role in the development of these diseases, environmental factors such as diet are also strongly related.

The new report reviewed different evidence on nutrition during pregnancy, breast-feeding and the first year of life that might affect the development of allergic disease. Its major findings are as follows:

• Currently, there is no evidence that what a mother eats during pregnancy or breast-feeding plays a major role in preventing atopic disease in infants. There is some evidence, however, that avoiding certain foods during breast-feeding may help prevent atopic eczema.
• Exclusive breast-feeding for at least four months for infants at high-risk of developing atopic disease decreases the risk of developing eczema and cow milk allergy during the first two years of life.
• In high-risk infants who aren't breast-fed exclusively for four to six months, the use of hydrolyzed infant formula (as opposed to formula containing cow milk) may delay or prevent the onset of atopic dermatitis.
• Exclusive breast-feeding for at least three months protects an infant against wheezing in early life.
• There is no good evidence to support the use of soy-based infant formula to prevent allergies.
• There is no evidence to suggest that delaying the introduction of solid foods before the recommended 4 to 6 months of age will have an effect on the development of atopic disease.
• There is no convincing evidence to suggest that any dietary intervention will prevent atopic disease after 4 to 6 months of age.

"It's a mixed picture," Wu said. "We don't have proven efficacy for breast-feeding. It may mean that we need more robust studies and a longer-term follow-up for kids."

The new report is titled "Effects of Early Nutritional Interventions on the Development of Atopic Disease in Infants and Children: The Role of Maternal Dietary Restriction, Breastfeeding, Timing of Introduction of Complementary Foods, and Hydrolyzed Formulas.

Effects of wet-wrap dressing on the epidermal barrier in atopic dermatitis

January 7, 2008

The therapeutic efficacy and mode of action of wet-wrap dressing was investigated in 10 patients (mean age 22 years) with severe form atopic dermatitis (AD). Wet-wrap dressings (4-5 layers of gauze hydrated with 0.9% saline) were applied for 8 h/day for 7-14 days. Immediately and 7 days post-treatment, SCORing Atopic Dermatitis (SCORAD) index, corneum water content, transepidermal water loss (TEWL) and the lipid amount of the skin surface were measured.

Post-treatment SCORAD scores were significantly lower after wet-wrap dressing (p<0.01> vs. pretreatment). Moreover, epidermal water content significantly increased and TEWL was significantly decreased after wet-wrap dressing. There was a significantly increased release of lamellar body and recovery of damaged lamellar structures post-treatment. Neither keratinocyte differentiation nor changes in calcium ion gradient were detected (Lee, J.H. et al. JEADV 2007, 21(10): 1360-1368).
Source:
http://www.accessdermatology.com/