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Fluticasone – topical

Classification: A

Drug products: Flutivate®

ATC code: D07AC17

Summary

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.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

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

Effects

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 the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2016-12-13

References

  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