Chemical formula: C₂₂H₂₇ClF₂O₄ Molecular mass: 428.9 g/mol PubChem compound: 5311167
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
A vasoconstrictor assay in healthy subjects with ulobetasol indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in a study of 25 adult subjects with moderate to severe plaque psoriasis involving a mean body surface area of 18.4%. A mean dose of 3.7 g ulobetasol was applied twice daily for two weeks and produced laboratory evidence of HPA axis suppression in 6 of 25 (24%) subjects. In this study, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone). These effects were reversible as recovery of HPA axis function was generally prompt with the discontinuation of treatment.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
In the HPA-axis and pharmacokinetic study, as described above in Clinical Pharmacology (12.2), pharmacokinetics was evaluated in a subgroup of 23 adult subjects with moderate to severe plaque psoriasis following twice daily treatment for 14 days with a mean daily dose of 7.4 g. Plasma concentration of halobetasol propionate was measureable in all subjects and steady state was achieved by Day 14. The mean (± standard deviation) Cmax concentration for ulobetasol on Day 14 was 199.7 ± 217.3 pg/mL, with the corresponding median Tmax value of 1 hour (range 0 – 12 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCt) was 1434.9 ± 1310.6 pg∙h/mL.
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