Efficacy and safety of 15(R/S)-methyl-lipoxin A(4) in topical treatment of infantile eczema.

Lipoxins are potential anti-inflammatory mediators and serve as an endogenous 'braking signal' in the inflammatory process. Accumulating evidence has indicated the efficacy of lipoxin A(4) (LXA(4) ) and its analogs in the treatment of many animal models of inflammatory diseases. This study investigates the efficacy and safety of 15(R/S)-methyl-lipoxin A(4) in the topical treatment of infantile eczema. In this two-centre, double-blind, placebo-controlled, randomized, parallel-groups comparative study, 60 patients were randomly assigned to receive either the 15(R/S)-methyl-lipoxin A(4) cream, mometasone furoate (Eloson, Schering-Plough, Shanghai, China) or placebo for 10days. The efficacy was determined using the Severity Scale Score (SSS), Eczema Area and Severity Index (EASI) and the Infants' Dermatitis Quality of Life Index (IDQOL). Safety was monitored by physical examination, laboratory investigation and documentation of clinical adverse events. The treatment of eczema with 15(R/S)-methyl-LXA(4) cream significantly relieved the severity, induced a recovery, and improved the quality of life of the patients, as demonstrated by significantly reduced SSS, EASI and IDQOL, respectively, in a way similar to the efficacy of Eloson. All safety parameters remained within normal limits. No clinical adverse event was found in the three patient groups. 15(R/S)-methyl-LXA(4) was well tolerated, and significantly reduced the severity of eczema. The results of this small exploratory study suggest that 15(R/S)-methyl-LXA(4) warrants further investigation in the treatment of eczema.