Verdeso foam, dermatop emollient cream.
(Verdeso [desonide] Foam 0.05%, Connetics Corp.)
The Food and Drug Administration approved Verdeso (desonide) Foam 0.05% for treatment of mild to moderate atopic dermatitis in patients 3 months and older. Recommended Dosage: Apply a thin layer of Verdeso Foam to affected area(s) twice daily.
Dispense by inverting the aluminum can.
* Special Considerations: Instruct patients to use Verdeso Foam for the shortest time necessary because of potential suppression of the hypothalamic-pituitary-adrenal (HPA) axis. In a 4-week study of 75 patients aged 6 months to 17 years treated with Verdeso Foam, 3 participants displayed adrenal suppression. The effect was transient and cortisol levels returned to normal when tested another 4 weeks later. Treatment should not exceed 4 consecutive weeks.
In a double-blind, randomized study, application site adverse events occurred in 6% of 387 pediatric patients (aged 3 months to 17 years) treated with Verdeso Foam versus 14% of 194 treated with a vehicle. Upper respiratory tract infection, application site burning, and cough were among commonly reported adverse events. The majority of adverse events were mild to moderate and transient.
Do not dispense the medication directly onto the face. Instruct parents or patients to dispense into hands and gently massage into affected areas of the face. Verdeso Foam can be applied directly to affected areas not on the face. Use with occlusive dressings is not recommended.
* Comment: Investigators in the double-blind, randomized study rated treatment as successful for 39% of patients applying Verdeso Foam twice daily for 4 weeks, compared with 9% of the patients using vehicle foam. Success was defined as an Investigator's Static Global Assessment (ISGA) score of clear or almost clear; a minimum improvement in the 5-point ISGA score of 2 grades from baseline to week 4; and a score of absent or minimal for both erythema and induration/papulation at week 4.
"Patients with atopic dermatitis are particularly sensitive to vehicles. Here is a product approved down to age 3 months. It's a corticosteroid with a strong safety record matched with a new vehicle technology," said Dr. Joseph Jorizzo, professor and former founding chair of the department of dermatology, Wake Forest University, Winston-Salem, N.C. "Patients younger than 2 years are more challenging to treat, so having this approval down to 3 months is a very nice advantage."
Existing medium- and high-potency foam products contain alcohol, which is perfect for areas with hair but can cause stinging in people with atopic dermatitis,
Dr. Jorizzo said. Verdeso foam is lower potency and alcohol free, and features an emollient base so it does not sting. "There is a tremendous amount of family resistance to therapies that sting. The difference [with this product] will come in terms of compliance."
Dr. Jorizzo is on the advisory board for Connetics.
Dermatop Emollient Cream (prednicarbate emollient cream 0.1%, Dermik Laboratories)
The FDA approved a new age range for
Dermatop (prednicarbate) Emollient Cream 0.1% for treatment of mild to moderate eczema. It is now indicated for use in patients aged 1 year and older.
* Recommended Dosage: Apply a thin layer to the affected skin areas twice daily. Rub in gently.
* Special Considerations: Safety and effectiveness have not been established for longer than 3 weeks in pediatric patients. Discontinue therapy when control of eczema is achieved, as with other corticosteroids.
Reassess if no improvement is observed after 2 weeks. Do not use this medium-potency corticosteroid with occlusive dressings or in the diaper area for children wearing diapers.
* Comment: Safety and efficacy in patients aged 1 year and older is based on an uncontrolled study of 59 pediatric patients. Participants were between 4 months and 12 years of age with atopic dermatitis. Mild signs of atrophy, shininess, and mild telangiectasia were reported in the study.
Although pediatric patients applying topical corticosteroids to greater than 20% of their body surface area are at a higher risk for HPA axis suppression, this effect was not observed in the study.
"The approval of Dermatop Emollient Cream down to the 1-year age group has some of the same advantages [as Verdeso Foam]--its being a safe product, and our now having data to give to parents showing this drug is safe," Dr. Jorizzo said. He was involved in initial studies of Dermatop cream but has no current affiliation with the product or company.
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|Title Annotation:||New & Approved|
|Date:||Nov 1, 2006|
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