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.

Mechanism of Action

Verdeso Foam is a topical corticosteroid that is 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.

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 percent of the pediatric subjects after four 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.

Dosing/Administration

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 Trial 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 four weeks. Of the subjects on the Verdeso treatment, 39 percent achieved success, defined as an Investigator's Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the five-point ISGA score of two grades from baseline to week four, and a score of absent or minimal for both erythema and induration/papulation at week four. Only 9 percent 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