A randomized, investigator-blinded efficacy assessment study of stand-alone emollient use in mild to moderately severe atopic dermatitis flares

Abstract

Background: Whereas emollients are integral to the long-term management of atopic dermatitis (AD), the evidence for their efficacy in disease flares is limited.

Objective: We aimed to investigate the stand-alone efficacy of an emollient formulation with regard to improvement of the clinical symptoms, skin barrier function and reduction of pathogenic bacterial colonization in acute stage of AD.

Materials and methods: Twenty AD volunteers aged 12-65 years with symmetric, mild to moderately severe inflammatory lesions on the forearms/arms were recruited for the study. At inclusion, the forearms/arms of each volunteer were randomized to receive for 1 week either an o/w formulation containing licochalcone A (Glycyrrhiza Inflata root extract), decanediol, menthoxypropanediol and ω-6-fatty acids (emollient arm) or 1% hydrocortisone (HC arm); after 1 week, the application of the emollient and HC were discontinued and the volunteers applied a w/o emollient containing licochalcone A and ω-6-fatty acids on both arms for further 3 weeks. The outcomes included reduction of the clinical and itch severity, decrease in S.aureus colonization, improvement of the barrier function, skin hydration and skin tolerability assessed after 1 week (D7) and after 4 weeks (D28) respectively.

Results: In both arms, there was a significant decrease in the severity score, itch intensity, erythema and TEWL on D7 and D28 compared to baseline. In addition, emollient use resulted in pronounced decrease in S.aureus colonization and significant increase of skin hydration on D7. The comparison of the outcomes, based on percentage change from baseline, showed no significant differences between the emollient and HC arm at any time point.

Conclusions: The results of the study indicate that the 1-week stand-alone application of an emollient, tailored to target inflammation, pruritus, compromised barrier function and pathogenic bacterial colonization may offer benefit for the improvement of mild to moderately severe localized flares of AD.