Bryhali lotion, a form of halobetasol propionate, was recently approved by the FDA for the treatment of plaque psoriasis. Bryhali is a superpotent topical steroid, also known as a Class I steroid. Other forms of generic halobetasol propionate are available, as well as a branded product called Ultravate. Generally, the use of superpotent topical steroids should be limited to brief periods, as long term use can cause side-effects such as thinning of the skin, striae, telangiectasia, and hypopigmentation. For this reason, previously approved formulations of halobetasol propionate are labelled to use for up to two weeks.
In contrast, Bryhali was studied for up to 8 weeks of application, and no increase in epidermal atrophy, or thinning, was noted. Bryhali will therefore be able to claim this on its label. It does not necessarily mean that the other forms of halobetasol propionate are unsafe for use greater than two weeks, only that they have not been studied. In the Bryhali clinical trial, the comparator group was an ointment vehicle and not another formulation of halobetasol.
Whether this medication gets adopted for the treatment of plaque psoriasis by the dermatology community is likely to be more dependent on its reimbursement than on the additional claim of 8 weeks of safety data.