Xepi (ozenoxacin) / Maruho, Cipher, Ferrer International - LARVOL DELTA

Comment on 'Effectiveness, safety and tolerability of ozenoxacin 2% lotion vs clindamycin 1% lotion in mild to moderate truncal acne': considerations regarding sample size and treatment-related withdrawal. (PubMed, Clin Exp Dermatol) - No abstract available

Journal • Acne Vulgaris

Effectiveness , safety and tolerability of Ozenoxacin 2% lotion vs Clindamycin 1% lotion in mild to moderate truncal acne : An open label randomized controlled clinical trial (EADV 2026) - No abstract available

Clinical • Acne Vulgaris

Novel topical antibacterial therapies (EADV 2026) - "These were followed by topical antibiotics such as Fucidin and Mupirocin although some of the topical azole antifungals, such as miconazole and econazole, also had good activity against bacteria such as Staph. These include :the development of new topically active antibacterial antibiotics such as ozenoxacin 1% or peceleganan,adapting nano particle technology to enhance penetration of existing antibacterials into the epidermisadopting innate mechanisms by using synthetic antimicrobial peptide compounds eg PXL150 or antibacterial enzymes or endolysins as treatments. While many of these developments are some distance from registration there is now a new wave of drug development focusing on novel approaches to enhance skin penetration or adaptation of innate forms of antimicrobial defense as well as novel antibiotics."

Infectious Disease

Effectiveness, safety and tolerability of Ozenoxacin 2% lotion vs Clindamycin 1% lotion in mild to moderate truncal acne: An open label randomized controlled clinical trial. (PubMed, Clin Exp Dermatol) - "Ozenoxacin demonstrated comparable efficacy and tolerability to clindamycin when used in combination with adapalene, in truncal acne."

Clinical • Journal • Acne Vulgaris • Dermatology

Adverse Childhood Experiences and Adolescent Mental Health Symptoms: The Role of Peer Interactions. (PubMed, J Child Adolesc Trauma) - "No significant interaction effects were found between ACEs and positive peer social interactions for internalising or externalising symptoms (p 's > .05). However, negative peer social interactions significantly exacerbated the relationship between ACEs and internalising and externalising symptoms over time (t(3912.300)= -2.86, p = .0.004; t(3906.79)=-0.200, p=.<0.001, respectively)."

Journal

Potential Role of Ozenoxacin 1% Cream in the Topical Management of Hidradenitis Suppurativa: A Single-centre Experience (44 patients). (PubMed, Acta Derm Venereol) - No abstract available

Journal • Dermatology • Hidradenitis Suppurativa • Immunology

Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin. (PubMed, J Biol Phys) - "Based on literature information on drug-resistance related study for DNA gyrase, we generated 4 different mutant models 3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H by inserting two mutations at each position 88 and 94 in DNA gyrase chain A. Antibiotics Clinafloxacin, Gatifloxacin, Moxifloxacin, Sitafloxacin, Prulifloxacin, Besifloxacin, Delafloxacin, Ozenoxacin were docked with 3ILW_wild to understand their stability, binding affinity, and interaction pattern with the wild-type DNA gyrase (3ILW_wild). It is worth noting that mutation at position 94 of DNA gyrase A has a very profound effect as it shows a positive contribution towards increased resistance due to reduced binding affinity with delafloxacin. This study explains the structural changes and mechanism behind the resistance against Delafloxacin, and may also guide the structural changes required in existing Delafloxacin or other antibiotics to develop new therapeutics to overcome the issue of resistance."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Ozenoxacin 1% in Pediatric and Adult Patients with Impetigo: A Meta-Analysis of Randomized Trials. (PubMed, J Clin Med) - " A systematic review and meta-analysis of randomized controlled trials (RCTs) comparing ozenoxacin 1% with placebo or mupirocin was conducted. Given the low heterogeneity observed, these findings support the clinical use of ozenoxacin for impetigo management. Future large-scale RCTs and direct comparative studies are warranted to further validate its therapeutic benefits."

Journal • Retrospective data • Review • Dermatology • Infectious Disease • Pediatrics

Ozenoxacin-Induced Contact Dermatitis With Tolerance to Ciprofloxacin. (PubMed, J Investig Allergol Clin Immunol) - No abstract available

Journal • Contact Dermatitis • Dermatitis • Dermatology • Immunology

Ecthyma secondary to varicella (EADV 2024) - "Patient was diagnosed and treated with Acyclovir for varicella 10 days prior to current lesions...Treatment included injectable Amoxicillin, Ceftriaxone, Vancomycin and Linezolid, potassium permanganate compresses and Ozenoxacin 1% cream... Factors associated with complications in varicella include topical, systemic, and inhaled steroids, immunosuppressants, NSAIDs, old-age, HIV, atopic dermatitis and low income. Although varicella complications were thought to be immune status dependent, immunocompetent children can be affected. In contrast to varicella gangrenosum which develops within 24-48 hours, secondary bacterial infections occur 10-14 days after an episode of varicella."

Atopic Dermatitis • Dermatitis • Dermatology • Human Immunodeficiency Virus • Immunology • Varicella Zoster

Ozenoxacin suppresses sebum production by inhibiting mTORC1 activation in differentiated hamster sebocytes. (PubMed, J Dermatol) - "Interestingly, nadifloxacin, but not clindamycin, exhibited a similar suppression of sebum production, albeit with lesser potency compared with ozenoxacin. Notably, it decreased the amount of TG on the skin surface. The results provide novel insights into the sebum-inhibitory properties of ozenoxacin, indicating its potential efficacy in controlling microbial growth and regulating sebum production for acne management."

Journal • Acne Vulgaris • Dermatology • SCD

In vitro activity of ozenoxacin against Staphylococcus aureus and Streptococcus pyogenes clinical isolates recovered in a worldwide multicentre study (2020-2022). (PubMed, JAC Antimicrob Resist) - "The most active comparators against S. aureus were retapamulin (MIC90 = 0.12 mg/L), fusidic acid (MIC90 = 0.25 mg/L) and mupirocin (MIC90 = 0.5 mg/L); and against S. pyogenes were retapamulin (MIC90 = 0.03 mg/L), clindamycin (MIC90 = 0.12 mg/L) and mupirocin (MIC90 = 0.25 mg/L). On the other hand, ozenoxacin had similar activity in ciprofloxacin-susceptible and resistant S. pyogenes isolates. Ozenoxacin is a potent antimicrobial agent of topic use against Gram-positive bacteria causing SSTI, including MRSA isolates non-susceptible to ciprofloxacin."

Journal • Preclinical • Infectious Disease

QbD Based Formulation Development and Optimisation of Ozenoxacin Topical Nano-Emulgel and Efficacy Evaluation Using Impetigo Mice Model. (PubMed, AAPS PharmSciTech) - "The systematic application of QbD principles facilitated the successful development and optimization of a Ozenoxacin Nano-Emulsion. Optimised Ozenoxacin Nano-Emulgel can be considered as an effective alternative and found to be stable at least for 6 months at 40 °C / 75% RH and 30 °C / 75% RH."

Journal • Preclinical • Dermatology

Formulation and optimisation of Ozenoxacin topical nano-emulgel including a comprehensive methodology to qualify and validate the critical parameters of an in-vitro release test method and ex-vivo permeation test. (PubMed, Drug Dev Ind Pharm) - "Results confirmed that IVRT and Reversed Phase - High Performance Liquid Chromatographic techniques were validated as per regulatory guidelines. In-vitro, ex-vivo drug release and skin retention from the optimized nano-emulgel formulation was comparatively higher (∼1.5 times) than that from the innovator (OZANEXTM) formulation. Based on these results, Ozenoxacin nano-emulgel can be considered an effective alternative and was found to be stable at 40 °C/75% RH and 30 °C/75% RH storage condition for 6 months."

Journal • Preclinical

Identification, characterisation and in silico ADMET prediction of ozenoxacin and its degradation products using high-performance liquid chromatography-photodiode array and liquid chromatography-quadrupole time-of-flight-tandem mass spectrometry. (PubMed, Rapid Commun Mass Spectrom) - "The drug was found to be stable in neutral, acidic, basic and oxidative degradation conditions with hydrogen peroxide. Liquid chromatography-electrospray ionisation-quadrupole time-of-flight-tandem mass spectrometry- was employed in positive ionisation mode to analyse both the drug and the mass of the identified DP. The mechanism and the pathway of mass fragmentation have been proposed. The developed method was accurate, repeatable, linear and selective for further research. The ADMET Predictor software was applied to predict the in silico toxicity of the drugs and its DPs as well as their physicochemical characteristics."

Journal • Dermatology

Single-center, prospective, and observational study on the management and treatment of impetigo in a pediatric population. (PubMed, Eur Rev Med Pharmacol Sci) - "Topical ozenoxacin has strong efficacy in treating impetigo in pediatric patients. Ozenoxacin's clinical and microbiological rapid onset of response led to consider this antibiotic a novel efficacy option for the treatment of impetigo."

Journal • Observational data • Dermatology • Infectious Disease • Pediatrics

"Tak til @MD5120 for gaven, samt tak til @ProfJLundgren og @IgumRasmussen for at tage sig tid til at skrive bogen, som giver et godt indblik i hele pandemien. Indeholder gode indlæg omkring mange af de emner der blev diskuteret intens for 1-2 år siden. Kan varmt anbefales👍" (,@MartinJuhl2)

Co-infection of Pseudomonas aeruginosa and Achromobacter xylosoxidans in green nail syndrome treated with ozenoxacin (WCD 2023) - "Ozenoxacin, the first nonfluorinated quinolone, could be a safe, topical treatment in case of MDR nail infections. Further studies are required to evaluate clinical isolation from nail infections and the co-presence of P. aeruginosa and A. xylosoxidans"

Cystic Fibrosis • Dermatology • Fibrosis • Immunology • Infectious Disease

Paradoxical hidradenitis suppurativa in a 16 year old patient with Crohn’s disease treated with Adalimumab (WCD 2023) - "Adalimumab discontinuation, and topical Ozenoxacin 1% three times a day were followed by a significant improvement of skin lesions...Further studies are needed to determine the most appropriate treatment choice toward ongoing biologic therapy in patients with CD 1) Salvatori S, Marafini I, Monteleone G. Paradoxical hidradenitis suppurativa in Crohn's disease patients receiving infliximab: a case report and review of literature. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e1046-e1050"

Clinical • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease

Retrospective Analysis of the Real-World Use of Topical Antimicrobials in the Paediatric Population with Impetigo in Italy: Focus on the Role of Ozenoxacin 1% Cream. (PubMed, Children (Basel)) - "In contrast, the rate of treatment failure was similar. Very few adverse reactions were identified."

Journal • Real-world • Real-world evidence • Retrospective data • Dermatology • Dermatopathology • Pediatrics

Ozenoxacin effectiveness in hidradenitis suppurativa (EHSF 2023) - "As systemic tetracyclines and quinolones have also demonstrated potent anti-inflammatory effect, they are widely accepted in the treatment of the hidradenitis suppurativa...According to other simultaneous treatment, they were included in three groups: no other treatment (naive), biological therapy (adalimumab, secukinumab and guselkumab) and oral antibiotic...Hurley stage, localization of the lesions and previous use of topical clindamycin were also included...Our study suggests that this non-fluorinated quinolone could decreased pain and suppuration of the lesions in patients with hidradenitis suppurativa specially those with mild Hurley stages and with lack of previous use of antibiotics. Although further studies are required, we propose the use of topical ozenoxacin in patients with hidradenitis suppurativa as useful alternative therapy in these patients."

Dermatology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Pain

Disproportionality analysis of quinolone safety in children using data from the FDA adverse event reporting system (FAERS). (PubMed, Front Pediatr) - "Most FAERS reports associated with ciprofloxacin (N = 2,706) followed by levofloxacin (N = 1,191), moxifloxacin (N = 375), oflaxacin (N = 245) and ozenoxacin (N = 187). Generally, the findings of this study are compatible with AEs recorded in package inserts. The unexpected signals of ozenoxacin justify active vigilance by clinicians and timely monitoring by pharmacovigilance experts."

Adverse events • Journal • Asthma • Cardiovascular • CNS Disorders • Epilepsy • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Disorders • Hypotension • Immunology • Infectious Disease • Mental Retardation • Musculoskeletal Diseases • Neutropenia • Pediatrics • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology

Clinical and economic consequences of ozenoxacin vs. other topical antibiotics for the treatment of impetigo: a real-life study in Spain. (PubMed, Glob Reg Health Technol Assess) - "Impetigo is a common dermatological paediatric infection that can be treated with topical antibiotics: the common are mupirocin (MUP), fusidic acid (FA) and, most recently, ozenoxacin (OZ). The percentage of patients ending treatment after 2 weeks was 87.6% (OZ) vs. 83.2% (MUP) vs. 82.4% (FA); p<0.001; complication rates were 1.8% (OZ), 3.3% (MUP) and 3.2% (FA), p<0.001; mean costs were €158 (OZ), €265 (MUP) and €287 (FA), p<0.001. OZ is a cost-effective and dominant alternative for the treatment of impetigo."

Journal • Dermatology • Infectious Disease • Pediatrics

"Esse xepi é uma vergonha, mais um brasileiro canalha" (,@fernando_lissa)

Antimicrobial activity of ozenoxacin and other antimicrobials against Staphylococcus aureus strains isolated from clinical skin specimens in Japan in 2019 and 2020. (PubMed, J Infect Chemother) - "The minimum inhibitory concentrations (MIC) of OZNX for MSSA and MRSA were 0.12 and 0.25 μg/mL, respectively, indicating that OZNX exhibited the same or stronger antibacterial activity than that of the other antimicrobials tested, such as nadifloxacin, fucidic acid, and gentamicin. Notably, a low MIC of OZNX was observed even for strains with reduced susceptibility to nadifloxacin, a similar quinolone-based topical antimicrobial. OZNX is a highly potent antimicrobial used in Japan for superficial skin infections caused by S. aureus, such as impetigo contagiosa and related diseases."

Journal • Dermatology • Infectious Disease