Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients

Abstract

Aim: To investigate the efficacy and tolerability of a cream (Rilastil Xerolact PB) containing a mixture of prebiotics and postbiotics, and to validate the PRURISCORE itch scale in the management of atopic dermatitis.

Methods: The study is based on 396 subjects of both sexes in three age groups (i.e., infants, children, adults) suffering from mild/moderate Atopic Dermatitis, recruited from 8 European countries and followed for 3 months.

Results: The product demonstrated good efficacy combined with good/very good tolerability in all age groups. In particular, SCORAD, PRURISCORE and IGA scores decreased significantly over the course of the study. The PRURISCORE was preferred to VAS by the vast majority of patients.

Conclusion: Even though the role of prebiotics and postbiotics was not formally demonstrated since these substances were part of a complex formulation, it can be reasonably stated that prebiotics and postbiotics have safety and standardization features that probiotics do not have. In addition they are authorized by regulatory authorities, whereas topical probiotics are not.

Keywords:

• Atopic dermatitis
• prebiotics
• postbiotics
• Quality of Life
• PRURISCORE

Acknowledgement

The authors would like to thank Dr Carlotta Galeone and Dr Claudio Pelucchi of Statinfo® company ([email protected]) for their kind support and advice.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes

1 Dupilumab is the first biological drug approved for the treatment of adults and children >6 years old with moderate to severe atopic dermatitis that is not adequately controlled with topical treatments or when these treatments are not indicated. Dupilumab is a human monoclonal antibody that inhibits the activity of IL-4 and IL-3, two cytokines that act as mediators of chronic Th2 inflammation characteristic of AD.

2 PRURISCORE is an itch assessment score, developed in 2006 by the lead author of this study, to overcome the limitations of the classic VAS system in use in SCORAD. The PRURISCORE is inspired by the pain scale of Wong and Backer and, according to the author, is more suitable to capture the intensity of a subjective symptom through a combination of pictograms and short descriptions of the same (see Figure 1).

3 Rilastil Xerolact PB Balsam is a product designed for the basic emollient treatment of AD, formulated with a prebiotic (alpha-glucan oligosaccharide) and a postbiotic (Lactobacillus ferment). These substances act in synergy with a moisturizing–relipidizing complex (sodium lactate, glycerine, shea butter) and an anti-itch complex (niacinamide 4%, vitamin E, dipotassium glycyrrhizinate). Lactobacillus ferment is composed of concentrated metabolites (oligopeptides, fatty acids and glycolipids) from bacterial fermentation of lactobacilli to protect the skin and its microbiota. There are no live microorganisms or residual bacterial fragments in the extract, thanks to an exclusive, patented extraction method (‘PBTech’ method) of the latest generation, the main innovation of which is that it is possible to generate these substances in the absence of a culture medium and thus obtain only the desired substances in pure form and without catabolites, bacterial fragments or whole contaminating cells, thus achieving a high degree of safety.

RILASTIL XEROLACT PB balm has the following INCI: Aqua (Water) • Triethylhexanoin • Glycerin • Polyglyceryl-3 Distearate • Butyrospermum parkii (Shea) Butter • Niacinamide • Methylpropanediol • C15-19 Alkane • Glyceryl Stearate • Sodium Lactate • Alpha-Glucan Oligosaccharide • Behenyl Alcohol • Glyceryl Stearate Citrate • Dipotassium Glycyrrhizate • Tocopheryl Acetate • Lactobacillus ferment • Schisandra chinensis Fruit Extract • Xanthan Gum • Mannitol • Lactic Acid • Chlorphenesin • o-Cymen-5-ol • Tetrasodium Glutamate Diacetate • Sodium Hydroxide • Parfum (Fragrance).

4 RILASTIL XEROLACT OLIO DETERGENTE has the following INCI: Aqua (Water) • Glycerin • PEG-7 Glyceryl Cocoate • Sodium Cocoamphoacetate • Sodium Lactate • Sodium Lauryl Glucose Carboxylate • PEG-90 Glyceryl Isostearate • Propanediol • Polysorbate 20 • Lauryl Glucoside • Sodium Chloride • Lactic Acid • Coco-Glucoside • Glyceryl Oleate • Oryza sativa (Rice) Bran Oil • Prunus amygdalus dulcis (Sweet Almond) Oil • Niacinamide • Schisandra chinensis Fruit Extract • Laureth-2 • Sodium Citrate • Caprylhydroxamic Acid • Citric Acid • Sorbic Acid • Tocopherol • Hydrogenated Palm Glycerides Citrate • Lecithin • Ascorbyl Palmitate • Parfum (Fragrance).

Additional information

Funding

This work was supported by the Istituto Ganassini di Ricerche Biochimiche.