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

Area of Science:

• Dermatology
• Endocrinology
• Pharmacology

Background:

• Topical corticosteroids are widely used for dermatological conditions.
• Assessing the potential for adrenal suppression is crucial for potent topical steroids.
• Understanding the comparative effects of different formulations is important for clinical practice.

Purpose of the Study:

• To compare the effects of a new 0.05% diflorasone diacetate ointment with established corticosteroids (fluocinonide, clobetasol propionate) and its vehicle on adrenal suppression.
• To evaluate plasma cortisol levels following the application of potent topical steroids over a 14-day period.

Main Methods:

• A 14-day, double-blind, randomized, in-clinic study involving 24 healthy male volunteers.
• Four treatment groups: 0.05% diflorasone diacetate ointment, 0.05% fluocinonide ointment, 0.05% clobetasol propionate ointment, and diflorasone diacetate vehicle.
• Application of medication to 75% of total body surface area once daily for six consecutive days.
• Measurement of plasma cortisol levels during pretreatment, treatment, and post-treatment periods.

Main Results:

• A decrease in plasma cortisol levels was observed in multiple subjects across all treatment groups during the study.
• Cortisol levels tended to return to baseline after cessation of therapy.
• No statistically significant differences in the degree of adrenal suppression were found between the diflorasone diacetate, fluocinonide, and clobetasol propionate treatment groups.
• The observed reduction in plasma cortisol was attributed to both the applied medications and environmental changes.

Conclusions:

• The tested topical corticosteroids, including diflorasone diacetate, fluocinonide, and clobetasol propionate, induced a temporary reduction in plasma cortisol levels.
• No significant differences in adrenal suppression were detected among the evaluated corticosteroid formulations under the study conditions.
• Further research may be warranted to explore long-term effects and specific patient populations.