A case of green nail syndrome secondary to P. aeruginosa and C. parapsilosis treated with topical nadifloxacin and oral fluconazole in a 31-year-old Filipino female

Introduction@#Pseudomonas aeruginosa is an opportunistic, gram-negative bacillus that can contaminate skin or open wounds to cause skin infections that are historically difficult to manage. The pathogenesis of green nail syndrome (GNS) begins with hyperhydration (occlusion, sweating, maceration) or destruction (microtrauma, dermatitis) of the epidermis thus disrupting the physical barrier, leading to the colonization and proliferation of P. aeruginosa. This case explores the off-label use of nadifloxacin, a fluoroquinolone approved for acne and bacterial skin infections in some countries, to treat a case of GNS. @*Case Report@#This is a case of a 31-year-old Filipino female who presented with a four-month history of green discoloration of the lateral portion of the right thumbnail with a medical history of antiphospholipid antibody syndrome and rheumatoid arthritis. Clinical examination showed a dystrophic thumbnail with greenish discoloration, erythema and swelling around the base of the cuticle, and distal onycholysis. Laboratory findings revealed co-infection of P. aeruginosa and Candida parapsilosis. The patient was effectively treated with topical nadifloxacin and oral fluconazole.@*Conclusion@#This case highlights the possibility of fungal and polymicrobial infections in GNS and suggests a novel, easy-to-use, and cost-effective alternative treatment to GNS secondary to P. aeruginosa in the form of topical nadifloxacin.

An evaluation of safety and efficacy of nadifloxacin 1% ointment versus mupirocin 1% ointment in Indian children with skin and soft tissue infection

Background: Although nadifloxacin has been shown to be effective in the treatment of skin & soft tissue infections (SSTI), there is a paucity of data comparing its efficacy and safety with other antibacterials, especially in Indian paediatric population. Therefore, objective of this study was to compare the safety and efficacy of nadifloxacin with mupirocin in children with SSTI.Methods: This was a single-centre, open label, randomized, parallel group, comparative study in 60 children of <12 years of age with SSTI. Test group (n=30) received nadifloxacin 1% ointment and reference group (n=30) received mupirocin 1% ointment, to be applied twice daily. Patients were followed up at day 4, 8 and 15. Efficacy of the study drugs was evaluated by clinical and bacteriological cure rate. Safety was assessed by reporting of adverse events.Results: Baseline characteristics of enrolled patients were comparable between treatment groups and all 60 patients completed the study. At Day 15, 100.0% cases among nadifloxacin group and 96.7% cases among mupirocin group achieved clinical cure (p=0.313). The most common bacteria found in culture were Gram positive cocci in both the groups (86.7% in nadifloxacin and 58.8% in mupirocin group). None of the cases in any of the groups showed bacteriological presence at day 15. No adverse event was reported in any of the treatment groups during the study duration.Conclusions: Nadifloxacin was found to be equally efficacious and safe to mupirocin in the treatment of SSTI in Indian pediatric population.

A rational pharmacotherapeutic study of comparative safety among topical anti-acne 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne vulgaris, in tertiary care hospitals

Background: Topical adapalene and tretinoin, are comedolytic, anti-comedogenic and anti-inflammatory, on RAR (?, ?, ?) receptors binding. Adapalene enables quicker follicular penetration, by lesser anti-AP-1 (c-Jun, c-Fos) and no CRBPII mRNA actions, causing chemical stability, lipophilicity and less photo-lability, producing lesser photosensitivity and no skin irritation, unlike tretinoin; wherein reducible by overnight application and combination therapy, slow-release polymers or emollients, respectively. Topical nadifloxacin is bactericidal, anti-inflammatory and comedolytic, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1?, IL-6, IL-8. The Global Alliance to Improve Outcomes in Acne Guidelines recommend synergistic and additive combination therapies, which enhance therapeutic efficacy and reduce adverse effects. Due to inadequacy of data, this study was conducted, to compare the safety among topical anti-acne monotherapies and combination therapies, and to easily detect any adverse effect producing component in the topical combination therapy.Methods: In this multi-centre, prospective, randomised, open-labelled, comparative study, groups A, B, C, D and E (20 patients each), applied topical 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, respectively, over their facial mild to moderate acne lesions, once daily overnight; and adverse effects, like erythema, scaling, dryness, prutitus, burning, or stinging, were assessed on 0, 15, 30, 60, 90 days and follow-ups, by Local Irritation Scale.Results: In all 5 groups, no adverse effects were observed, with no statistically significant difference among the observations.Conclusions: The therapies were well tolerated and safe among all 5 groups.

Impact on quality-of-life: before and after topical combinational treatment in patients of acne vulgaris.

Background: The objective was to study quality-of-life in patients of acne vulgaris before and after treatment by benzoyl peroxide 2.5% gel and clindamycin 1% gel or benzoyl peroxide 2.5% gel and nadifloxacin 1% cream or tretinoin 0.025% and clindamycin 1% gel. Methods: This was a prospective, open, randomized, parallel comparative study of 60 patients of acne vulgaris attending the Department of Dermatology and Venereal Diseases, Government Medical College, Rajindra Hospital, Patiala. Three groups were made 20 in each group, one group received benzoyl peroxide 2.5% gel and clindamycin 1% gel, the second group received benzoyl peroxide 2.5% gel, and nadifloxacin 1% cream and the third group received tretinoin 0.025% and clindamycin 1% gel. Cardiff acne disability index questionnaire was filled before starting and after the treatment. Results: In these three groups, it was found that the group on benzoyl peroxide 2.5% gel and clindamycin 1% gel, mean score, before starting treatment was 8.35±3.48 and after treatment was 2.95±2.09 (p<0.001), group on benzoyl peroxide 2.5% gel and nadifloxacin 1% cream, mean score, before starting treatment was 7.60±3.75 and after treatment was 5.80±2.98 (p<0.001) and group on tretinoin 0.025% and clindamycin 1% gel mean score is 8.00±3.06 and after treatment was 5.40±2.93 (p<0.001). Conclusion: Quality-of-life improves more in patients taking benzoyl peroxide 2.5% gel and clindamycin 1% gel, and then, tretinoin 0.025% and clindamycin 1% gel and then benzoyl peroxide 2.5% gel and nadifloxacin 1% cream.

Evaluation of Efficacy and Skin Irritation during Treatment of Nadifloxacin 1% Cream in Acne Vulgaris Patient / 대한피부과학회지

BACKGROUND: Nadifloxacin is a synthetic fluoroquinolone with a broad spectrum. It has been suggested to not only have antibacterial, but also anti-inflammatory actions. In addition, it is effective against antibiotic-resistant Propionibacterium acne. Upon review of the literature, however, no studies have been performed concerning the efficacy and safety in terms of irritation potential and skin barrier changes after applying nadifloxacin. OBJECTIVE: This study intended to evaluate the skin irritation and changes of the skin barrier function associated with the administration of nadifloxacin 1% cream for the treatment of acne vulgaris. Furthermore, the efficacy and safety of nadifloxacin 1% cream were also assessed. METHODS: The changes in the lesion counts, Korean Acne Grading System (KAGS) and adverse events were recorded. The biophysical profiles of the skin, including transepidermal water loss (TEWL), skin surface hydration and redness were measured by Tewameter(R), Corneometer(R) and Mexameter(R) for 3 weeks. RESULTS: At the end of the therapy, 69% of inflammatory lesions (p<0.0001) and 27% of noninflammatory lesions (p=0.26) resulting from acne were decreased from the baseline. Adverse events were reported in two patients, but they were transient and tolerable. The skin barrier function showed no changes during the treatment periods. CONCLUSION: Nadifloxacin 1% cream is effective for the treatment of acne vulgaris without the changes of skin barrier function.

Clinical Efficacy and Tolerance of 1% Nadifloxacin Cream in the Treatment of Mild to Moderate Acne Vulgaris in South Korea / 대한피부과학회지

BACKGROUND: Antimicrobials have been a mainstay of inflammatory acne treatment for more than 30 years. However, antibiotic-resistant propionibacteria had been isolated with increased frequency, and associated with failure to respond to antibiotic therapy. OBJECTIVE: The aim of this study was to investigate the clinical efficacy and tolerance of 1% nadifloxacin cream. METHODS: In the final analysis, 197 patients with mild to moderate facial acne vulgaris were enrolled. The patients were instructed to apply 1% nadifloxacin cream twice daily to the affected skin after washing the face. Following 2 and 4 weeks of treatment, patients were observed for clinical response: number of the acne lesions, Korea acne grading system (KAGS), global improvement, and occurrence of adverse reactions. RESULTS: During 4 weeks of treatment, nadifloxacin caused significant reduction in the number of inflamed papulo-pustular lesions and open/closed comedones. In addition, significant reduction of KAGS was observed. About 96% of patients showed clinical improvement in the overall evaluation of the therapeutic effect by physicians. All reported adverse events were mild. CONCLUSION: This study shows that 1% nadifloxacin cream can be an effective and safe treatment for mild to moderate acne vulgaris.