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Fluticasone – topical

Classification: A

Drug products: Flutivate®

ATC code: D07AC17


There are some studies with analyses of sex differences in effect of fluticasone cream/ointment but the results are contradictory and the clinical relevance is unclear.

Additional information

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding  pharmacokinetics and dosing of fluticasone have been found.


A placebo controlled study in patients with atopic eczema (156 male, 216 female) a reduction in the risk of flare development and lengthening of the time to the first flare after application of fluticasone 0.05% cream was demonstrated and subgroup analyses showed no difference between men and women regarding the primary efficacy parameter [1].In an another placebo controlled study (29 boys, 46 girls) assessing the efficacy and safety of fluticasone 0.005% ointment in the maintenance treatment of children with atopic dermatitis, a highly statistically significant treatment effect was observed in girls (p < 0.001) [2]. The authors suggested that compliance factors and treatment preferences (i.e. perhaps boys do not like ointment-based formulations) may have influenced the results. However, the total number of boys was small and there was an imbalance in ratio of boys/girls between treatment groups; 13 (33%): 26 (67%) in the fluticasone group and 16 (44%):20 (56%) respectively in the placebo group.  

Adverse effects

Both men and women have been included in most of the safety studies of topical fluticasone cream/ointment. However, no analysis of sex differences have been found and sex-divided data is lacking [2, 3].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2020-08-28

Date of litterature search: 2016-12-13


  1. Hanifin J, Gupta AK, Rajagopalan R. Intermittent dosing of fluticasone propionate cream for reducing the risk of relapse in atopic dermatitis patients. Br J Dermatol. 2002;147:528-37. PubMed
  2. Glazenburg EJ, Wolkerstorfer A, Gerretsen AL, Mulder PG, Oranje AP. Efficacy and safety of fluticasone propionate 0005% ointment in the long-term maintenance treatment of children with atopic dermatitis: differences between boys and girls?. Pediatr Allergy Immunol. 2009;20:59-66. PubMed
  3. Roeder A, Schaller M, Schäfer-Korting M, Korting HC. Safety and efficacy of fluticasone propionate in the topical treatment of skin diseases. Skin Pharmacol Physiol. 2005;18:3-11. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-12-27.] Socialstyrelsens statistikdatabas

Authors: Alaa Falemban, Maria Enghag

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson