Chinese Journal of Dermatology

• Original articles • Previous Articles     Next Articles

A multicentre,randomized,double-blind,placebo-controlled study on the efficacy and safety of interleukin-8 monoclonal antibody cream in the treatment of eczema

CUI Pan-gen1, LIN Lin1, BI Zhi-gang2, LUO Dan2, ZHANG Fu-ren3, TIAN Hong-qing3, LIAN Shi4   

  1. Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing 210042, China
  • Received:2005-12-23 Online:2006-04-15 Published:2006-04-15

Abstract: Objective To evaluate the efficacy and safety of interleukin-8 monoclonal antibody (IL-8 monAb) cream (45 p.g/g) in the treatment of eczema.Methods A multicentre,randomized,doubleblind,placebo-controlled study was performed.The patients were randomly divided into two groups to receive IL-8 monAb cream (45μg/g) or vehicle,twice daily for 3 weeks.All the patients were evaluated prior to the treatment,and 1,2,3 weeks after the therapy,with clinical effects as well as adverse drug reactions recorded.Results Two hundred and twenty-nine patients were recruited in four clinical centers,and 209 patients completed the trial,of whom 104 were in the treatment group and 105 in the control group.All symptom/sign total scores were significantly decreased (all P<0.05)1,2,3 weeks after the treatment in the treatment group compared with those in the control group.Efficacy assessment based on symptom/sign reducing index (SSRI) showed statistical difference in the cure rates (27.88% vs.2.86%,P<0.05) and responsive rates (56.73% vs.15.24%,P<0.05) between the treatment and control groups.Five (4.71%) patients experienced side effects of burning,local erythema and worsening of itch in the treatment group,and 2 (1.79%)in the control group.The rates of side effects were of no significant difference (P>0.05)between the two groups.No systemic side effects were found.Conclusion Topical use of IL-8 monAb cream (45μg/g) is safe and effective for the treatment of eczema.

Key words: Eczema, Interleukin-8, Antibodies,monoclonal, Randomized controlled trials