Topical fluticasone propionate lotion does not cause HPA axis suppression.
OBJECTIVE
To establish the absence of adrenal suppression of fluticasone propionate (FP) 0.05% lotion when applied extensively to children (3 months to 6 years), with moderate to severe atopic dermatitis (AD).


METHODS
Open-label, conducted at 6 US centers; 44 subjects (3 to 71 months) with widespread AD (mean body surface area treated, 65%) received FP lotion twice daily for up to 4 weeks.


RESULTS
No significant differences in mean cortisol levels were detected before or after treatment. At baseline, mean (+/-standard deviation) cortisols before and after cosyntropin (CST) stimulation were 13 +/- 6 microg/dL and 35 +/- 6 microg/dL, respectively. End-treatment, pre-CST, and post-CST cortisols were 12 +/- 6 microg/dL and 33 +/- 8 microg/dL, respectively. All 42 subjects with end-treatment post-CST cortisols demonstrated a normal adrenal response to CST (>18.0 microg/dL). FP lotion was well tolerated. Subjects who had blood drawn for bioavailability showed no correlation between FP levels and end-treatment post-CST cortisols.


CONCLUSIONS
In patients as young as 3 months, FP lotion had no effect on HPA axis function and did not cause skin thinning even when used extensively over widespread, severe inflammatory disease. These results, together with others from studies using cream and ointment, provide further evidence of the safety of FP.
Hebert
Adelaide A
AA
Department of Dermatology, University of Texas-Houston Medical School, 6655 Travis Street, Houston, TX 77030, USA.
Friedlander
Sheila Fallon
SF
Allen
David B
DB
D000279:Administration, Cutaneous; D000730:Androstadienes / Q000008:administration & dosage*; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000097:blood* / Q000473:pathology; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004655:Emulsions; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000097:blood*; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D007223:Infant; D008297:Male; D010913:Pituitary-Adrenal System / Q000187:drug effects*
D000730:Androstadienes; D003879:Dermatologic Agents; D004655:Emulsions; D000068298:Fluticasone; D006854:Hydrocortisone