Topical fluticasone propionate lotion does not cause HPA axis suppression

Area of Science:

• Dermatology
• Pediatrics
• Endocrinology

Background:

• Atopic dermatitis (AD) is a common inflammatory skin condition in children.
• Topical corticosteroids are a mainstay treatment for AD, but concerns exist regarding systemic absorption and potential side effects.
• Fluticasone propionate (FP) is a potent topical corticosteroid used to manage AD.

Purpose of the Study:

• To evaluate the safety of fluticasone propionate (FP) 0.05% lotion in pediatric patients with moderate to severe atopic dermatitis (AD).
• Specifically, to determine if extensive application of FP lotion leads to adrenal suppression.
• To assess the impact of FP lotion on hypothalamic-pituitary-adrenal (HPA) axis function in young children.

Main Methods:

• An open-label study was conducted across 6 US centers.
• 44 pediatric subjects aged 3 to 71 months with widespread AD (mean 65% body surface area) received FP 0.05% lotion twice daily for up to 4 weeks.
• Adrenal function was assessed by measuring cortisol levels before and after cosyntropin (CST) stimulation at baseline and end-treatment.

Main Results:

• No significant differences in mean cortisol levels were observed before and after FP lotion treatment.
• All subjects demonstrated a normal adrenal response to cosyntropin stimulation at the end of the treatment period.
• Fluticasone propionate lotion was well-tolerated, with no correlation found between FP levels and adrenal function.

Conclusions:

• Fluticasone propionate (FP) 0.05% lotion does not cause adrenal suppression in children as young as 3 months old, even with extensive use.
• The study provides evidence that FP lotion is safe for HPA axis function and does not cause skin thinning in pediatric patients with severe AD.
• These findings support the overall safety profile of FP formulations in pediatric dermatology.