Efficacy and Microbiota Modulation Induced by LimpiAL 2.5%, a New Medical Device for the Inverse Psoriasis Treatment

Abstract

(1) Inverse psoriasis (IP), also known as intertriginous, typically affects the groin, armpits, navel, intergluteal fissure, and external genitalia. Skin lesions are erythematous plaques of inflammatory nature, smooth, well-delimited, non-scaly, and non-infiltrated. Lesions may be accompanied by itching, pain, or burning sensation. The aim of this study is both to investigate the modulation of the skin microbiota induced by IP and, on the other hand, to test the effectiveness of the new biotechnological product LimpiAL 2.5%. (2) Patients affected by IP were recruited in a private practice and treated for 4 weeks with LimpiAL 2.5% exclusively. The clinical effects on the lesion skin were evaluated, and the skin microbiotas before and after treatment were compared. (3) The clinical outcomes reveled a significant beneficial effect of the tested product. At the same time, LimpiAL increased the biological diversity of the skin microbiota and exerted a significant decrease of some Corynebacterium species, and the increase of some Staphylococcus species. (4) Together, the clinical outcomes and the microbiota analysis suggest that LimpiAL treatment improves the skin condition of affected patients, basically restoring the eubiosis conditions of the affected sites and modulating the bacterial composition of the resident microbiota.

Keywords: Actinobacteria; Corynebacterium; Firmicutes; Staphylococcus; fold; intertriginous; inverse; microbiota; psoriasis; treatment.

Figure 1

Clinical outcomes. In the first light-blue column, the body area sampled is indicated. The pink, blue, and green columns report the score and the percentage variation (Δ) of PASI, DLQI, and itch VAS indexes, respectively. In the yellow columns, the tick and cross symbols indicate whether the swab was collected or not collected.

Figure 2

Statistical comparison between the (a) PASI, (b) DLQI, and (c) itch VAS scores registered before and after the LimpiAL treatment (Wilcoxon test, p ≤ 0.05).

Figure 3

The sequencing output from the NGS Illumina MiSeq of 16S and ITS amplicons libraries. (a) The number of reads obtained. (b) The number of matched OTUs. The grey horizontal line highlights the average value.

Figure 4

The modulation trends of OTUs in compared microbiota. The number of (a) modulated, (b) differential, (c) under and (d) over-represented, and (e) exclusive OTUs is reported with respect to each compared microbiota. The orange and blue colors indicate the OTUs of T0 and T1 microbiota compared to the CTRL ones. The violet color depicts the OTUs varied in the T1 microbiota with respect to the T0 microbiota. The asterisk indicates the statistical significance of comparisons, with * standing for p < 0.05.

Figure 5

OTU modulation dependence of the taxonomical level. (a) Distribution of the under- and over-represented, differential, and exclusive OTUs along the taxonomical levels for all comparisons between microbiotas. (b) Abundance (%) of the under- and over-represented, differential, and exclusive OTUs is reported, and the highest abundance for each taxonomical level and comparison is highlighted in bold character.

Figure 6

Taxa differentially modulated between the compared microbiotas (DESeq2 analysis, p-value, and FDR ≤ 0.05). After the underscore, the capital letter P, C, and O stand for phylum, class, and order, respectively.

Figure 7

Comparison between the modulation trends detected in T0 and T1 microbiota for the ten most under (bars to the left side) and ten most over (bars to the right side) modulated OTUs.

Figure 8

The sequencing output from the Shotgun sequencing. (a) The number of reads obtained. (b) The number of matched OTUs. The grey horizontal line highlights the average value.

Figure 9

The percentage abundance of principal domains in T.0 (inner ring) and T.1 (outer ring) microbiota.

Figure 10

Statistical comparison between the prevalence of principal domains detected in the microbiotas before (T.0) and after (T.1) the LimpiAL treatment (unpaired Student’s t-test and Kolmogorov–Smirnov test, both with p ≤ 0.05).

Figure 11

Statical comparison between the percentage distributions at the upper (phylum and class) and lower (genus and species) taxonomic levels (Student’s t- and Wilcoxon test with p ≤ 0.05). Red and blue symbols depict respectively T.0 and T.1 taxa distributions.

Figure 12

Taxa differentially modulated by the LimpiAL treatment in the microbiota of inguinal (light blue) and mammary fold (dark blue). (a) The phylogenetic relationship between modulated microbes (a) and the type and level of modulation induced (logFC) (b) are reported. Bars oriented to the left with negative numbers indicate a significant decrease of the detected taxon; bars oriented to the right with positive numbers highlight the increment.

Figure 13

Study set-up and workflow. The different skin conditions and treatments are highlighted by colors: green for patients with healthy skin (CTRL), orange for IP patients, and light blue for IP patients treated with LimpiAL 2.5%. The same colors are used for related swabs. The application of LimpiAL 2.5% is graphically represented by the medical device blue tube. The camera icon indicates that photos of sampled areas have been collected. The identical patient’s icon is used when the same patients are considered in different groups.