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SkinMedica(R) Presents Three Scientific Posters at the 65th Annual Meeting of the American Academy of Dermatology: Data Support Use of New Desonate(TM) (Desonide) Gel 0.05% With Patented Hydrogel Technology for Treatment of Mild-to-Moderate Atopic Dermati

Posted on: Monday, 5 February 2007, 09:01 CST

CARLSBAD, Calif., Feb. 5 /PRNewswire-FirstCall/ -- SkinMedica, Inc., a specialty pharmaceutical company focused on developing, acquiring, and commercializing products that treat dermatologic conditions and diseases and improve the appearance of skin, announced today that three clinical posters supporting the benefits of Desonate(TM) (desonide) Gel 0.05% will be presented at the 65th Annual Meeting of the American Academy of Dermatology (AAD), to be held February 2-6, 2007, in Washington, D.C.

Desonate was developed by SkinMedica and Dow Pharmaceutical Sciences, Inc., in a collaborative agreement. Desonate is a low-potency topical steroid (desonide) formulated in Dow's proprietary water-based Hydrogel Technology. Approved by the U.S. Food and Drug Administration (FDA) in October 2006, Desonate will be commercially available on February 12, 2007, and will be co-promoted by SkinMedica and Galderma Laboratories, L.P. SkinMedica will promote Desonate to the dermatology market, while Galderma will promote Desonate to pediatricians via its specialized pediatric sales force.

Desonate, which has been approved by FDA for the treatment of atopic dermatitis in patients aged 3 months and older for up to four consecutive weeks, is an appropriate therapy for both pediatric and adult patients. Desonate is the first and only atopic dermatitis treatment formulated with the patented Hydrogel Technology. This versatile formulation can be used on hair-bearing and non-hair-bearing skin, and is free of alcohol, fragrance, or surfactants that can be irritating or drying to the skin.

"We believe the depth and breadth of our clinical findings, as presented at this year's AAD meeting, demonstrate Desonate's Hydrogel advantage," said Rex Bright, President & CEO of SkinMedica. "The data illustrate that Desonate provides an effective new treatment option for physicians and their patients. Moreover, the patient preference study suggests that patients will embrace the attributes of the Hydrogel vehicle."

The scientific posters are summarized here: Safety and Efficacy of Desonide Hydrogel 0.05% in Pediatric Subjects With Atopic Dermatitis

A total of 425 subjects were treated with Desonate and 157 subjects were treated with the Hydrogel vehicle twice daily for 4 weeks. Desonate 0.05% was extremely well tolerated and provided statistically significant improvements in all primary (P < 0.001) and secondary (P < / = 0.006) efficacy endpoints. Subjects in the active group experienced significant clearing of disease, with a rapid reduction of body surface area affected as early as Week 2. At the end of treatment, 58% of Desonate-treated subjects had their disease assessed as clear or almost clear by Investigator's assessment.

Atopic Dermatitis: Advantages of a Novel Hydrogel Vehicle

In Phase III studies, signs and symptoms of atopic dermatitis were noticeably reduced in both the Desonate-treated group and the vehicle group. Results from a separate hydration and barrier study demonstrated the moisturizing potential of the Hydrogel vehicle, further reinforcing the non-drying effects of this aqueous gel.

Topical Vehicle Preferences in Atopic Dermatitis Patients -- Evaluating a Novel Hydrogel Vehicle

Results from this user preference study showed that the majority of subjects ( > / = 84%) found the Hydrogel vehicle easy to apply; suitable for use on multiple body areas, including hair-bearing skin; comfortable to have on their skin under clothing and make-up; non-greasy; absorbs quickly; and non-drying. Seventy-five percent (75%) of subjects rated this vehicle as superior to other gels they had used, and eighty-eight percent (88%) of subjects would be compliant with this vehicle as part of a treatment regimen. Ninety-four percent (94%) would be willing to use products formulated with this vehicle on their children.

Posters will be presented at the 65th Annual Meeting of the American Academy of Dermatology in Washington, DC.

Hall C -- Washington Convention Center February 2-5, 2007 (Times vary by date.) About Atopic Dermatitis

Atopic dermatitis affects more than 15 million patients, resulting in rash, redness, swelling, crusting, and scaling of the skin. The disease affects nearly 20% of infants and young children, some of which continue to experience symptoms as adults. The exact cause 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 U.S. physicians for inflammatory dermatoses.

Additional Information About 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 (866) 867-0110.

About SkinMedica

SkinMedica is a privately held specialty pharmaceutical company marketing both prescription and cosmeceutical dermatology products. SkinMedica's Desonate(TM) (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 cosmeceutical products, which is sold through physicians, 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/.

About Galderma Laboratories, L.P.

Created in 1981 as a joint venture between Nestle and L'Oreal, Galderma Laboratories is the number-one dermatology company in the world, according to a recent IMS D-Class survey. With a worldwide presence in 65 countries, over 1000 sales representatives, and one of the largest research facilities dedicated to dermatology, Galderma provides innovative therapeutic skin care solutions to meet the needs of dermatology patients and physicians. The company is committed to improving the health of skin with an extensive line of products that treat a range of skin care conditions, including acne, rosacea, fungal nail infections, psoriasis, seborrheic dermatitis, hyperpigmentation disorders, non-melanoma skin cancer, and photodamage. With a new research lab in Sophia Antipolis, France, and the introduction of exciting technology and products on the horizon, Galderma is poised to continue making significant impact in dermatology treatment. For more information, visit http://www.galdermausa.com/.

Desonate(TM) is a trademark of SkinMedica, Inc.

SkinMedica(R), EpiQuin(R) Micro, NeoBenz(R) Micro, NouriCel-MD(R), TNS Recovery Complex(R), and VANIQA(R) are registered trademarks of SkinMedica, Inc.

CONTACT: Michelle Saunders Vice President, Pharmaceutical Marketing (760) 448-3673 msaunders@skinmedica.com

SkinMedica, Inc.

CONTACT: Michelle Saunders, Vice President, Pharmaceutical Marketing,SkinMedica, Inc., +1-760-448-3673, msaunders@skinmedica.com

Web site: http://www.galdermausa.com/

Web site: http://www.skinmedica.com/

Source: PRNewswire-FirstCall

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