General Information

Desonate 0.05% gel contains desonide, a synthetic nonfluorinated topical corticosteroid. These compounds have anti-inflammatory, antipruritic and vasoconstrictive properties.

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

Desonate is supplied as a gel for topical administration. The recommended initial dose of the drug is a thin layer applied to the affected areas two times daily and rubbed in gently. Treatment duration should not exceed four weeks.

Clinical Results

FDA Approval
FDA approval of Desonate was based on the results of two clinical trials. These multi-center, randomized, double-blind, placebo-controlled studies enrolled a combined 582 pediatric patients (ages 3 months to 18 years), who received topical administration of the drug or placebo (vehicle gel) twice daily for 4 weeks. Treatment success was defined as achieving clear or almost clear on the Investigator’s Global Severity Score (IGSS) with at least a 2 point change (decrease) from the subject’s baseline IGSS when compared to the Week 4 IGSS. Results revealed that in clinical trial 1, treatment success was achieved by 44% of the subjects treated with Desonate versus 14% of the subjects treated with placebo. In clinical trial 2, success was achieved by 28% of the subjects treated with Desonate versus 6% of the subjects treated with placebo.

Ongoing Study Commitments

Dow has committed to to conducting a dermal carcinogenicity study in Tg.AC mice with Desonate (desonide) Gel 0.05%.
Protocol Submission: November 2007
Study Start: August 2008
Final Report Submission: May 2010

Dow has committed to conducting a study to determine the photoco-carcinogenic potential of Desonate (desonide) Gel 0.05%, (13 week Photosafety study in mice).
Protocol Submission: August 2007
Study Start: February 2008
Final Report Submission: February 2009

Side Effects

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

Headache

Application site burning

Rash

Application site pruritus

In addition, systemic absorption of Desonate, as well as other topical corticosteroids, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Systemic absorption is augmented by the application of topical corticosteroids over large body surface areas, prolonged use or the addition of occlusive dressings. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

Mechanism of Action

Desonate Gel contains desonide, a synthetic nonfluorinated corticosteroid for topical dermatologic use. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties, however the general mechanism of action is unclear. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is thought that these proteins 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. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

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.

Freeman S, Howard A, Foley P, Rosen R, Wood G, See JA, Gray S Efficacy, cutaneous tolerance and cosmetic acceptability of desonide 0.05% lotion (Desowen) versus vehicle in the short-term treatment of facial atopic or seborrhoeic dermatitis. The Australasian Journal of Dermatology 2002 Aug;43(3):186-9.

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.