Bioequivalence of 0.1% mometasone furoate lotion to 0.1% mometasone furoate hydrogel.

BACKGROUND/OBJECTIVES: Vehicles used for topical therapy can affect drug delivery and patient adherence. This study compared the bioequivalence of 0.1% mometasone furoate lotion (reference) and 0.1% mometasone furoate hydrogel (test). Moisturising capacity and sensitivity/irritancy potential were also determined.

METHODS

Bioequivalence was assessed by vasoconstriction assay and analysis of area under the effect curve (AUEC0-24 ) according to the Food and Drug Administration (FDA) guidance. In total, 131 individuals were screened in a pilot dose duration-response study, and 90 responders enrolled. For the pivotal study, lotion and hydrogel (5 mg/cm(2) ) were applied in a double-blind manner. Vasoconstriction was evaluated by chromameter at 0, 2, 4, 6, 19 and 24 h following lotion and hydrogel removal. Barrier function was measured by assessment of transepidermal water loss (TEWL) and skin hydration. Sensitivity/irritancy potential was assessed by repeat insult patch tests.

RESULTS

The mean AUEC0-24 of the test hydrogel and reference lotion were -18.200 and -18.953, respectively, with test/reference = 96%, with 90% confidence interval (0.81, 1.12), which was within FDA guidance limits. TEWL was found to significantly decrease by 43 and 29% after 2 and 24 h, respectively, while skin hydration significantly increased by 38% after 24 h following a single application of hydrogel. The hydrogel was also found to be non-irritating and non-sensitising. No adverse events were observed.

CONCLUSIONS

Mometasone furoate hydrogel is bioequivalent to mometasone furoate lotion. This novel hydrogel formulation provides effective drug delivery, increases moisturisation and affords greater ease and tolerability of application, improving patients' adherence to therapy.