Physicians are currently finding products for pediatric respiratory diseases of viral etiology to reduce the inappropriate use of antibiotic therapy. This study evaluated PediaFlù (Pediatrica S.r.l.), a dietary supplement already on the market composed of honey, propolis, Pelargonium sidoides extract, and zinc (DSHPP), in children affected by acute tonsillopharyngitis (ATR). The open-label, randomized, and controlled study compared DSHPP + standard of care (SoC) versus SoC alone for six days. Children between 3 and 10 years with an ATR ≤ 48 h, a negative rapid test for beta-hemolytic Streptococcus, or a culture identification of nasal and/or pharyngeal exudates were included. A tonsillitis severity score (TSS) and the number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) were the primary endpoints. DSHPP+ SoC showed better performance than SoC alone for TSS sub-scores: throat pain and erythema on day 6 (p < 0.001 and p < 0.05), swallowing (p < 0.01 on day 4), and TSS total score on days 4 and 6 (p < 0.05 and p < 0.001). Only one patient (SoC group) had treatment failure for ibuprofen administration. No adverse events were reported. DSHPP is an optimal adjuvant in the treatment of URTI and could potentially be useful in the daily clinical practice of paediatricians evaluating the correct antibiotic prescription.

Background: A dietary supplement containing Pelargonium sidoides extract, propolis, zinc, and honey has been recently developed and proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders. Objective: This trial aims to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis (ATR). Methods: The trial includes children aged between 3 and 10 years with ATR ≤48 h, a negative rapid test for beta-hemolytic streptococcus or culture identification of nasal and/or pharyngeal exudates, and SARS-CoV-2 infection. The dietary supplement tested is an oral solution already on the market based on Pelagon P-70 (equivalent to Pelargonium sidoides d.e. 133.3 mg/100 ml), propolis, zinc, and honey. The product is administered at 5 ml 3 times a day for 6 days for children younger than 6 years and 10 ml 3 times a day for 6 days for children older than 6 years. The study design is open label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from 3 sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary end points. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 (SD 3.85) points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children. Results: Patient enrollment began on June 3, 2021 (first patient’s first visit), and ended on August 12, 2021 (last patient’s last visit). The data collection period was from June 3, 2021, to September 16, 2021. The study was funded in February 2023. Data analysis is currently ongoing (April 2024). We expect the results to be published in a peer-reviewed clinical journal in the third quarter of 2024 and presented at scientific meetings in the last quarter of 2024. Conclusions: The data from this trial may help identify new adjuvant treatments for children with ATR when streptococcal infection is excluded by a negative rapid test, thereby avoiding unnecessary antibiotic administration. Trial Registration: ClinicalTrials.gov NCT04899401 https://clinicaltrials.gov/study/NCT04899401 International Registered Report Identifier (IRRID): DERR1-10.2196/53703

Pediatrica Srl develop a dietary supplement (DSPP) with extract of Pelargonium sidoides (Pelagon P 70™), specific for paediatric age for the well-being of the airways. The scientific literature currently available shows that the extract ofPelargonium sidoides may be effective in the treatment of disorders affecting the respiratory tract. Moreover, the DSPP also contains zinc, honey, and propolis. A long tradition of use and literature support the use of zinc, propolis and honey for seasonal disease prevention and/or in the acute phase of colds. In addition to this, the specific formulation of propolis (PropolNext® PLUS) contained in the DSPP showed to be able to inhibit bacterial growth to a much greater extent if compared to simple propolis. The DSPP is currently on the market in Italy as adjuvant in seasonal diseases and its effectiveness has been evidenced in the daily clinical practice of thousand of paediatricians in this country. The present clinical trial was planned to confirm the results of standard clinical practice. Therefore, its aim was to explore if in paediatric patients affected by acute tonsillopharyngitis / rhinopharyngitis (ATR) a 6-day administration of the tested DSPP along with the standard of care (SoC) could improve the ATR symptomatology in comparison with patients receiving SoC alone.

Background: Medical literature shows there is no ideal treatment for acne, but topical therapies like benzoyl peroxide, retinoids, and antibiotics have proven to improve mild–moderate cases. Replacing benzoyl peroxide (potentially irritating) with hydrogen peroxide has already been suggested in the medical literature.Aims: We investigated a medical device, a proprietary combination of hyaluronic acid, hydrogen peroxide, and glycine in mild–moderate acne vulgaris.Methods: Patients of both sexes between ≥ 18 and ≤ 45 years old, with a Global Acne Grading System score ≤ 30, were included. Exclusion criteria were dermal systemic or infectious diseases; allergy to the tested product; pregnant or lactating women; treatment for acne 30 days before baseline; and previous facial aesthetic surgery. Forty patients were treated for 8 weeks several times a day with the tested product and visited at baseline, week 2, week 4, and week 8. Outcomes were decreasing the total number of lesions and the Global Acne Grading System Severity Score, Investigator Global Assessment of Performance with photographs evaluation in blind, Dermatology Life Quality Index, and the Treatment Satisfaction Questionnaire. Adverse events were collected for safety.Results: A 2‐fold decrease in the number of lesions at the final visit (−56.3%, p < 0.001). The remaining outcomes evidenced a statistically significant reduction at the final visit. Only 8 adverse events (all mild and related to the tested device) were reported.Conclusions: Results and optimal safety demonstrate that the tested product has a clinical benefit and could be associated with retinoids, as first choice for mild to moderate acne.Trial Registration: Clinicaltrial.gov as NCT05345093

Background/Objectives: Acute tonsillopharyngitis (ATR), typically caused by viruses, is a common reason for consultation with pediatricians. A dietary supplement with Pelargonium sidoides extract, propolis, honey, and zinc has been proposed as an effective adjuvant for the treatment of respiratory tract infections. This study aimed to verify, in a setting of standard clinical practice, the efficacy of this dietary supplement plus standard of care (SoC) versus SoC alone in a pediatric population affected by ATR. Methods: This open randomized study (registered on ClinicalTrials.gov: NCT 04899401) involved three Romanian sites specialized in pediatric care. The primary endpoints were changes in Tonsillitis Severity Score and the number of treatment failures (evaluating the use of ibuprofen or high-dose paracetamol as rescue medicine). One hundred and thirty children, divided into two groups, were enrolled and treated for six days. Results: The results showed an overall better performance in terms of efficacy of dietary supplement + SoC, compared to SoC alone, with lower total Tonsillitis Severity Score ratings and lower sub-scores (swallowing on day 4 and throat pain and erythema on day 6). No adverse events were reported. Investigators found compliance to be optimal. Conclusions: The administration of the dietary supplement + SoC in pediatric patients with ATR was found to be safe and superior to the administration of SoC alone in terms of efficacy. The results confirmed the tested dietary supplement as an optimal effective adjuvant in the treatment of respiratory tract infections and useful in the daily clinical practice of the paediatricians.