Double-blind, randomised, multicentre controlled clinical trial comparing the clinical efficacy of LimpiAD 1% and 2.5% versus the base LimpiAD formulation (without functional ingredient) in paediatric patients with mild to moderate atopic dermatitis. The study enrolled 59 subjects aged 6–12 years and received ethics committee approval in December 2019. Results demonstrated that LimpiAD is safe and effective in improving signs and symptoms of atopic dermatitis.

This study investigated changes in the sacral skin microbiota following the application of LimpiAD (2.5% Plus) as a preventive strategy against pressure ulcer development. The clinical trial was conducted as a collaborative project between Aileens Pharma, Gea Medica of Isernia, and the European Institute of Rehabilitation. Seventeen patients were enrolled after providing written informed consent, including authorization from family members where required.During the study period, none of the patients treated with LimpiAD developed pressure ulcers throughout their hospital stay. Microbiological analysis after 15 days of treatment showed no statistically significant changes in the composition of the sacral skin microbiota. Overall, LimpiAD appeared to help maintain microbiota homeostasis, potentially preventing dysbiosis conditions that may contribute to the onset of skin ulceration.

In this clinical study the effects of LimpiAL on the skin microbiota of patients with psoriasis were investigated. Microbiota profiling, performed using NGS on the Illumina MiSeq platform and shotgun sequencing, revealed a statistically significant reduction in specific Corynebacterium species, which are known to be more abundant on both lesional and non-lesional skin of psoriasis patients compared with healthy controls. In parallel, a significant increase was observed in several Staphylococcus species, including S. pasteuri, S. gallinarum, Staphylococcus sp. B-3, and Staphylococcus sp. SBT120. Notably, S. pasteuri is reported to produce the bacteriocin pasteuricin, which can inhibit the growth of Staphylococcus aureus. From a clinical standpoint, the study showed a marked improvement in disease severity and patient-reported outcomes. The PASI score decreased from a mean value of 6 ± 3 SD to 3 ± 3 SD, corresponding to a mean reduction of 64% (Figure 2a). The DLQI index showed an even greater improvement, decreasing from 14 ± 6 SD to 3 ± 5 SD, with a reduction of 77% (Figure 2b). Finally, the itch VAS score decreased from 38 ± 21 SD to 8 ± 18 SD, corresponding to an 85% reduction.

This pilot, randomized, double-blinded, prospective clinical trial evaluated the efficacy and tolerability of LimpiAC 2.5%, a novel biotechnological medical device, in patients with mild to moderate acne vulgaris (GEA 1–3). Twenty-four subjects were enrolled, of whom twenty-three completed the study. Patients were treated for 60 days with twice-daily topical application, with evaluations at baseline (T0), 30 days (T1), and 60 days (T2).

The primary endpoint was the change in acne severity assessed by the Global Evaluation of Acne (GEA) scale and lesion count. Secondary endpoints included the Global Acne Grading System (GAGS) score and exploratory microbiome assessments.

A progressive and statistically significant improvement in acne severity was observed. Mean GEA score decreased from 2.26 at baseline to 1.50 at day 30 and 1.09 at day 60 (p ≤ 0.05). Similar significant reductions were observed in both lesion count and GAGS score over the study period. No adverse events were reported, and the treatment was well tolerated.

Overall, LimpiAC 2.5% demonstrated a favourable efficacy and safety profile in mild to moderate acne vulgaris, supporting its potential role as a topical non-pharmacological option in acne management.

Skin biopsies from Sus scrofa infected with Staphylococcus aureus ATCC 29213 and S. aureus DSM20491 α-toxin were analysed using haematoxylin–eosin staining to assess damage to the stratum corneum. In all samples pre-treated or co-incubated with c40 and HAc40 suspensions, histological evaluation showed preserved tissue architecture, with morphological features comparable to the uninfected control. Immunofluorescence analysis of two key tight junction proteins, Claudin-1 and ZO-1, revealed a marked loss of signal in tissues infected with S. aureus or exposed to DSM20491 α-toxin, suggesting that host–pathogen interactions primarily target tight junction integrity during skin infection. In contrast, infected tissues treated with c40 and HAc40 maintained a staining pattern for both Claudin-1 and ZO-1 comparable to that observed in controls, indicating a protective effect against junctional disruption. Furthermore, both pre-incubation with c40 and HAc40, and co-incubation with HAc40, effectively prevented S. aureus-induced structural damage. Overall, c40 and the functional ingredient HAc40 appear to exert a protective, non-pharmacological action by counteracting bacterial toxin–induced degradation of the skin barrier and helping to preserve tissue integrity, with potential implications for the maintenance of a healthy skin microbiome.

The objective of this study was to evaluate the efficacy of a c40, alone and in combination with a mucopolysaccharide carrier (HAc40), in counteracting the pathogenic potential of extracellular vesicles (EVs) produced by Staphylococcus aureus ATCC 14458. In vitro experiments conducted on HaCaT keratinocyte cells demonstrated that treatment with HAc40 and c40 significantly modulated both the size and pathogenic properties of S. aureus EVs. In particular, EVs exhibited an increase in size, which may reduce their capacity to interact with target cells and consequently diminish their cytotoxic potential. Moreover, the EV-induced upregulation of tight junction-related genes, including zona occludens 1 (ZO-1) and claudin-1 (CLDN1), was attenuated in the presence of HAc40 and c40, suggesting a stabilizing effect on epidermal barrier function.Overall, these findings indicate that HAc40 and c40 may mitigate the detrimental effects of S. aureus EVs, supporting a potential protective role in maintaining skin barrier integrity.

This single-center pilot study evaluated the feasibility and safety of ultra-hypofractionated breast radiotherapy delivered using an automated hybrid-VMAT technique, with a focus on acute skin toxicity. Thirty patients with early-stage breast cancer (T1–T2, N0) were enrolled.

All patients used LimpiAD as a supportive topical treatment aimed at preserving skin integrity and reducing inflammation throughout the radiotherapy course. Skin toxicity was assessed clinically and instrumentally using the Cutometer®, measuring skin firmness (R0) and elasticity (Q1).

Acute grade 2 skin toxicity occurred in 13.3% of patients, while late grade 2 toxicity at six months was observed in 10%. One month after treatment, no significant correlation was found between instrumental measurements and clinical findings. At six months, however, a significant association emerged between reduced skin firmness and elasticity (R0 ≥24% and Q1 ≥18%) and clinically evident late skin toxicity (p = 0.003 and p = 0.022, respectively).

The low incidence of skin toxicity, together with supportive use of LimpiAD, suggests a potential benefit in maintaining skin integrity during treatment.

This study evaluated the impact of different supportive skin care strategies during whole-breast radiotherapy using advanced IMRT/VMAT techniques, with a specific focus on LimpiAD 2.5% Plus.

A total of 472 breast cancer patients were retrospectively–prospectively analyzed and divided into two groups: standard emollient care (n=315) and LimpiAD® (n=157). Acute skin toxicity was assessed using CTCAE v5.0.

Results showed a clear reduction in skin toxicity in the LimpiAD® group. Moderate–severe reactions (>Grade 2) occurred in 6.4% of patients using LimpiAD, compared to 15.6% in the standard care group (p < 0.004). Mild toxicity was also significantly lower with LimpiAD® (30.6% vs 65.4%, p < 0.001), corresponding to an overall reduction of approximately 50% in skin adverse events.

Overall, the data suggest that LimpiAD may significantly improve skin tolerance during breast radiotherapy, reducing both mild and clinically relevant dermatitis when compared to standard emollient treatments.