Adrenal suppression with high-potency corticosteroid ointment formulations in normal subjects

In this 14-day, double-blind, in-clinic study, 24 healthy male volunteers were assigned at random to one of four treatment groups to compare the effects of a new formulation of 0.05% diflorasone diacetate ointment in a vehicle of propylene glycol (PG) with the effects of ointments of 0.05% fluocinonide, 0.05% clobetasol propionate, or the vehicle for diflorasone diacetate PG. The medication was applied to 75% of each subject's total body surface once a day for six consecutive days. During treatment and four days before and four days after treatment, various indicators of adrenal suppression were measured. A reduction in plasma cortisol levels was seen in several patients in each treatment group during the pretreatment period (days 1-4). Plasma cortisol continued to decrease during treatment and tended to return to pretreatment levels after cessation of therapy. There were no statistically significant differences between treatment groups. The lowering of plasma cortisol values in all groups was attributed to the applied medications as well as to the volunteers' change in daily routine and environment.