General Information

Verdeso (desonide) Foam is a petrolatum-based emulsion aerosol foam containing the active ingredient desonide, a low-potency topical corticosteroid. Desonide is a white powder or crystal that is practically insoluble in water, sparingly soluble in ethanol and in acetone, and soluble in chloroform.

Verdeso is specifically indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Verdeso is supplied in 100 g aluminum cans. The recommended initial dose of the drug is a thin layer applied to the affected area(s) twice daily. The smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer should be used.

Clinical Results

FDA Approval
FDA approval of Verdeso was based on results of one clinical trial. This double-blind, randomized trial enrolled 581 subjects, ages 3 months to 17 years old, with mild to moderate atopic dermatitis, who received Verdeso Foam applied twice daily for 4 weeks. Of the subjects on the Verdeso treatment 39% achieved success, 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. Only 9% of the subjects on placebo achieved success.

Ongoing Study Commitments

Connetics has agreed to commit to conducting a dermal carcinogenicity study with Verdeso (desonide) Foam.
90-day dose range-finding study: By April 1, 2008
Study protocol submission: By October 1, 2008
Study start date: By June 1, 2009
Final report submission: By December 1, 2012

Connetics has agreed to commit to conducting a study to determine the photoco-carcinogenic potential of Verdeso (desonide) Foam.
90-day dose range-finding study: By April 1, 2008
Study protocol submission: By October 1, 2008
Study start date: By June 1, 2009
Final report submission: By December 1, 2011

Side Effects

Adverse events associated with the use of Verdeso may include, but are not limited to , the following:

Upper respiratory tract infection

Cough

Application site burning

Application site reaction

Viral infection

Headache

Irritability

Asthma

In addition, in a clinical study Verdeso was shown to cause adrenal suppression in 4% of the pediatric subjects after 4 weeks of use. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Verdeso Foam is contraindicated in subjects who are hypersensitive to desonide or to any ingredient in this preparation. Treatment should not exceed four consecutive weeks.

Mechanism of Action

Verdeso Foam is a topical corticosteroid which are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins are believed to control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Literature References

Wong VK, Fuchs B, Lebwohl M Overview on desonide 0.05%: a clinical safety profile. Journal of Drugs in Dermatology 2004 Jul-Aug;3(4):393-7

Lucky AW, Grote GD, Williams JL, Tuley MR, Czernielewski JM, Dolak TM, Herndon JH, Baker MD Effect of desonide ointment, 0.05%, on the hypothalamic-pituitary-adrenal axis of children with atopic dermatitis. Cutis; cutaneous medicine for the practitioner 1997 Mar;59(3):151-3.

Jorizzo J, Levy M, Lucky A, Shavin J, Goldberg G, Dunlap F, Hinds A, Strelka L, Baker M, Tuley M, et al Multicenter trial for long-term safety and efficacy comparison of 0.05% desonide and 1% hydrocortisone ointments in the treatment of atopic dermatitis in pediatric patients. Journal of the American Academy of Dermatology 1995 Jul;33(1):74-7.

Tarayre JP, Aliaga M, Barbara M, Ballester R, Tisne-Versailles J, Couzinier JP Comparison of the cutaneous/systemic antiinflammatory activity ratios for desonide and hydrocortisone in various experimental models. Arzneimittelforschung1988 Apr;38(4):542-5.