Effects of ozenoxacin: A Synthesis of Findings from 18 Studies

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Original Abstract of the Article

Major Research Findings

Ozenoxacin is a novel, non-fluorinated topical quinolone antimicrobial that has demonstrated efficacy in treating impetigo, a common bacterial skin infection in children. 3 Clinical trials have reported high clinical and microbiological success rates with ozenoxacin, suggesting it could be a valuable treatment option in an era of increasing antimicrobial resistance. 3 Ozenoxacin exhibits a unique mechanism of action, targeting both DNA gyrase and topoisomerase IV, and demonstrating low selection of resistant mutants. 3 Furthermore, ozenoxacin appears to be less susceptible to efflux pumps, which contribute to bacterial resistance to other quinolones. 3 These factors, coupled with its lack of a fluorine atom, contribute to its improved safety profile compared to traditional fluoroquinolones. 3

Benefits and Risks

Benefits Summary

Ozenoxacin has shown effectiveness against a wide range of Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). 8 It has a low likelihood of developing resistance, and its topical application minimizes the risk of systemic side effects. 、 8 Ozenoxacin is well-tolerated and has minimal potential for irritation, sensitization, phototoxicity, or photoallergy. 11 Studies have demonstrated that ozenoxacin does not penetrate deeply into the skin, further minimizing the risk of systemic side effects. 13 、 10

Risks Summary

While ozenoxacin is generally well-tolerated, potential risks include mild skin reactions such as erythema and pruritus. 2 Like other quinolones, it might carry a risk of arthropathy, particularly in juvenile animals. 18 However, studies have shown that oral administration of ozenoxacin in juvenile rats and dogs did not result in chondrotoxicity. 18 The long-term safety of ozenoxacin still requires further investigation.

Comparison between Studies

Commonalities between Studies

The majority of studies have consistently shown ozenoxacin to be effective against Gram-positive bacteria, especially those responsible for skin infections. 2 、 8 、 6 Furthermore, ozenoxacin demonstrates a low rate of resistance development, suggesting its potential for long-term effectiveness. 12 、 17

Differences between Studies

While the studies generally show positive results, there are differences in the specific types of skin infections targeted, the dosages used, and the duration of treatment. 2 、 8 、 6 Further research is needed to determine the optimal use of ozenoxacin in various clinical settings. 2 、 8 、 6

Consistency and Contradictions in Findings

The results of numerous studies support the efficacy and safety of ozenoxacin in treating Gram-positive bacterial skin infections. 2 、 8 、 6 However, some studies have observed variations in effectiveness and safety based on factors such as dosage and duration of treatment. 2 、 8 、 6 Continued research is necessary to fully understand the optimal application of ozenoxacin.

Practical Application Notes

Ozenoxacin offers a promising treatment option for Gram-positive bacterial skin infections, especially those resistant to other antibiotics. 2 、 8 、 6 However, self-medication is strongly discouraged. 2 、 8 、 6 Seeking medical advice and undergoing proper diagnosis are crucial before using any medication, including ozenoxacin.

Current Research Limitations

Research on ozenoxacin is still ongoing, and long-term safety data remains limited. 2 、 8 、 6 Further studies are needed to evaluate its long-term safety and efficacy across different patient populations. 2 、 8 、 6

Future Research Directions

Future research should focus on evaluating the long-term safety of ozenoxacin, its efficacy in treating a wider range of skin infections, and its comparative effectiveness against other available treatments. 2 、 8 、 6

Conclusion

Ozenoxacin represents a promising new treatment option for Gram-positive bacterial skin infections, demonstrating effectiveness and a favorable safety profile. 2 、 8 、 6 However, it is essential to consult with a medical professional for diagnosis and treatment. 2 、 8 、 6 Further research will provide more comprehensive insights into its effectiveness and long-term safety. 2 、 8 、 6

Literature analysis of 18 papers
Positive Content
17
Neutral Content
0
Negative Content
1
Article Type
5
0
1
5
18
1.

Pharmacodynamic effects of oral oxymorphone: abuse liability, analgesic profile and direct physiologic effects in humans.

Author: BabalonisShanna, LofwallMichelle R, NuzzoPaul A, WalshSharon L

Pain relief
Abuse potential
Respiratory depression

Oxymorphone is a semisynthetic μ-opioid agonist marketed as a prescription analgesic. This study compared the pharmacodynamic effects of oxymorphone and oxycodone in opioid abusers. Oxymorphone was less potent than oxycodone on most pharmacodynamic measures, but at higher doses, its abuse liability was similar to oxycodone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

2.

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial.

Author: RosenTheodore, AlbaredaNuria, RosenbergNoah, AlonsoFernando García, RothSandra, ZsoltIlonka, HebertAdelaide A

Impetigo treatment
Rapid onset
Well tolerated
Side effects

Topical ozenoxacin is effective and well tolerated in the treatment of impetigo in patients 2 months and older. It was found to be superior to placebo in both clinical and microbiological success. Topical ozenoxacin represents a novel option for the treatment of impetigo.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Ozenoxacin: a review of preclinical and clinical efficacy.

Author: VilaJordi, HebertAdelaide A, TorreloAntonio, LópezYuly, TatoMarta, García-CastilloMaría, CantónRafael

Impetigo treatment
Antimicrobial resistance

Impetigo, a common bacterial skin infection, is increasingly challenging to treat due to antimicrobial resistance. Ozenoxacin, a new topical quinolone antimicrobial, shows promising efficacy against impetigo, including against resistant strains of Staphylococcus aureus. This review examines the properties, clinical efficacy, and microbiological benefits of ozenoxacin.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Do Antimicrobial Resistance Patterns Matter? An Algorithm for the Treatment of Patients With Impetigo.

Author: SchachnerLawrence A, AndriessenAnneke, BenjaminLatanya T, ClaroCristina, EichenfieldLawrence F, EspositoSusanna Mr, KellerLinda, KircikLeon, KwongPearl C, McCuaigCatherine

Antimicrobial resistance

An evidence-based impetigo treatment algorithm was developed for pediatric and adult populations that addresses the growing concern of antimicrobial resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

A comparative review of current topical antibiotics for impetigo.

Author: GalindoEugenio, HebertAdelaide A

Impetigo treatment
Topical antibiotics
Pruritus

Topical antibiotics, such as mupirocin, ozenoxacin, and retapamulin, are effective in treating impetigo in children. These antibiotics show minimal adverse effects, with pruritus at the application site being the most common. Mupirocin is the least expensive option, but bacterial cultures are recommended to rule out resistance.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

6.

Topical Ozenoxacin Cream 1% for Impetigo: A Review

Author: SchachnerLawrence, AndriessenAnneke, BhatiaNeal, GradaAyman, PateleDillon

Impetigo treatment
Antibiotic resistance

This review examined the challenges in treating impetigo (a bacterial skin infection) in children and adults. The review also discussed the use of ozenoxacin 1% cream, a new topical treatment for impetigo, and its safety and effectiveness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Ozenoxacin: A Novel Drug Discovery for the Treatment of Impetigo.

Author: SahuJagdish K, MishraArun K

Bactericidal activity
Treatment of impetigo
Genotoxicity

Ozenoxacin, a non-fluorinated quinolone antibiotic, inhibits DNA gyrase A and topoisomerase IV, demonstrating bactericidal activity against Staphylococcus aureus and Staphylococcus pyogenes. It is currently approved for impetigo and shows promise for other dermatological bacterial infections. No genotoxicity was observed in experimental testing.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Ozenoxacin: A Novel Topical Quinolone for Impetigo.

Author: WrenChristopher, BellEdward, EilandLea S

Efficacy
Safety
High cost

Ozenoxacin, a topical quinolone, is a safe and effective treatment for impetigo in patients 2 months and older. However, further research is needed to compare its efficacy to currently recommended therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Cumulative irritation, sensitizing potential, phototoxicity and photoallergy of ozenoxacin in healthy adult volunteers.

Author: GropperSavion, CeperoAna Luisa, DosikJonathan S, LaStellaPhillip, SiemetzkiHeinrich, Wigger-AlbertiWalter

No phototoxicity
Skin tolerance
Minimal erythema

This study evaluated the safety of ozenoxacin 1 and 2% cream formulations in healthy volunteers. Both formulations were well tolerated and showed little or no tendency to cause irritation, sensitization, phototoxicity, or photoallergy. Only a few adverse events were reported, and virtually all were considered unrelated or unlikely to be related to ozenoxacin application.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

12.

In vitro selection of mutants resistant to ozenoxacin compared with levofloxacin and ciprofloxacin in Gram-positive cocci.

Author: LópezY, TatoM, EspinalP, Garcia-AlonsoF, Gargallo-ViolaD, CantónR, VilaJ

Skin infection treatment

This study examined the frequency of spontaneous resistance mutations to ozenoxacin, a des-fluoro-(6)-quinolone, in 49 quinolone-susceptible and -resistant Gram-positive cocci strains. The probability of selecting spontaneous resistant mutants was low for ozenoxacin compared to levofloxacin and ciprofloxacin. These findings support the potential utility of ozenoxacin in the treatment of skin infections caused by strains resistant to other quinolones.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Skin tissue exposure of once- versus twice-daily topical ozenoxacin 2% cream: a Phase I study in healthy volunteers.

Author: GropperSavion, AlbaredaNuria, SantosBenjamin, FebbraroSalvatore

Good skin penetration

This Phase I study examined the skin penetration of ozenoxacin 2% cream in healthy volunteers. Ozenoxacin concentrations were high in the stratum corneum and were approximately twofold greater for the twice-versus once-daily application. Ozenoxacin concentrations were low in the epidermis and were higher for the twice- versus once-daily application. Ozenoxacin concentrations in the dermis were below the limit of quantitation on most study days.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers.

Author: GropperSavion, AlbaredaNuria, SantosBenjamin, FebbraroSalvatore

No systemic absorption
Application site reactions

This Phase I study examined the systemic bioavailability and safety of topical ozenoxacin in healthy volunteers. No systemic absorption was observed, and ozenoxacin was well tolerated. The most common treatment-related adverse events were application-site reactions (erythema and pruritus), but the differences in local tolerability between ozenoxacin and placebo were not clinically significant.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

16.

In vitro activity of Ozenoxacin against quinolone-susceptible and quinolone-resistant gram-positive bacteria.

Author: LópezY, TatoM, EspinalP, Garcia-AlonsoF, Gargallo-ViolaD, CantónR, VilaJ

Dermatological infections

This study compared the in vitro activity of ozenoxacin, a novel nonfluorinated topical quinolone, with other quinolones against Gram-positive bacteria. Ozenoxacin was found to be significantly more active than other quinolones, suggesting its potential for the topical treatment of dermatological infections.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Studies on articular and general toxicity of orally administered ozenoxacin in juvenile rats and dogs.

Author: González BorrotoJorge Ignacio, AworiMalaika Sharon, ChouinardLuc, SmithSusan Y, TarragóCristina, BlazquezTeresa, Gargallo-ViolaDomingo, ZsoltIlonka

No chondrotoxicity
Well-tolerated

Ozenoxacin, a nonfluorinated quinolone antibacterial, was well-tolerated in juvenile rats and dogs and did not show evidence of quinolone-induced arthropathy, suggesting its safety for use in treating impetigo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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