|Year : 2015 | Volume
| Issue : 1 | Page : 16-18
Topical 2% mupirocin versus 2% fusidic acid versus 1% nadifloxacin cream in the treatment of superficial bacterial infections of the skin
Resham J Vasani1, Sudhir V Medhekar2
1 Consultant Dermatologist, Anand Polyclinic, Matunga, India
2 Professor and Head of Department, Government Medical College, Aurangabad, India
|Date of Web Publication||1-Dec-2015|
Resham J Vasani
C 1, 22, Karmakshetra, Near Shanmukhananda Hall, Sion , Mumbai- 37, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Topical mupirocin, fusidic acid, and nadifloxacin are used in the treatment of superficial bacterial infections. This study was undertaken to assess the efficacy and safety of these three topical antibiotics in the treatment of superficial bacterial infection of the skin. Aims: To compare the efficacy and safety profile of 2% mupirocin versus 2% fusidic acid versus 1% nadifloxacin cream in the treatment of superficial bacterial infections. Materials and Methods: A randomized study in treatment-naive cases of uncomplicated bacterial skin infections attending the out-patient Department of Dermatology was done. A total of 90 patients of bacterial infections of the skin were included, which were randomly allocated to three different study groups. After diagnosis was confirmed clinically, grading of the lesions was done with regard to parameters such as erythema, edema, vesiculation, pustulation, crusting, and scaling. Score was applied to each parameter as 0-absent, 1-mild, 2-moderate, and 3-severe. Gram staining was performed. The lesions were graded on subsequent visits on day 4, day 18, and day 14. The results were subjected to analysis of variance test, followed by the Dunnett's test. Results: Fusidic acid cream showed faster reduction of the scores at the end of the first visit. The differences noted in the efficacy of the three drugs were not statistically significant. No significant side effects were observed. Conclusion: This study documents the equality in the comparative safety and efficacy of mupirocin, fusidic acid, and nadifloxacin in the treatment of uncomplicated superficial bacterial infections at our center.
Keywords: Fusidic acid, mupirocin, nadifloxacin, superficial skin infection
|How to cite this article:|
Vasani RJ, Medhekar SV. Topical 2% mupirocin versus 2% fusidic acid versus 1% nadifloxacin cream in the treatment of superficial bacterial infections of the skin. Indian J Drugs Dermatol 2015;1:16-8
|How to cite this URL:|
Vasani RJ, Medhekar SV. Topical 2% mupirocin versus 2% fusidic acid versus 1% nadifloxacin cream in the treatment of superficial bacterial infections of the skin. Indian J Drugs Dermatol [serial online] 2015 [cited 2019 Jul 20];1:16-8. Available from: http://www.ijdd.in/text.asp?2015/1/1/16/170744
| Introduction|| |
Dermatologists are faced with an ever-changing spectrum of bacterial infection in cutaneous diseases. Studies have stated that uncomplicated bacterial skin infections may account for up to 17–25% of clinical visits in India.,, This high incidence of bacterial infections is due to various precipitating factors such as low socioeconomic status, poor hygiene, malnutrition, overcrowding, and certain immunodeficiency syndromes. Bacterial skin infections can also complicate other skin diseases such as scabies, varicella, and atopic dermatitis. Majority of the bacterial skin infections are caused by Group A beta-hemolytic Streptococcus and Staphylococcus.
Topical antibacterials are used to accelerate clinical cure, prevent recurrences in affected individuals, and to minimize the spread of infection. They are considered more appropriate as they target only infected area and thus avoid the side effects of the oral treatment and the associated drug interactions. Indiscriminate and universal use of topical medications including antibiotics has led to widespread resistance (molecular, group, and class) to the same. A review of literature did not reveal any study comparing the three commonly used topical antibacterial agents - mupirocin, fusidic acid, and nadifloxacin. Therefore, a randomized study was done to compare safety and efficacy of topical nadifloxacin, topical mupirocin, and fusidic acid cream in the treatment of uncomplicated superficial bacterial infections of the skin.
| Materials and Methods|| |
This study was carried out in the patients attending the out-patient Department of Dermatology and Venereology of a tertiary care center with primary objective to compare the efficacy and safety profile of 2% mupirocin vis-a-vis 2% fusidic acid cream vis-a-vis 1% nadifloxacin cream in the treatment of superficial bacterial infections.
The study group comprised of 90 patients of superficial bacterial infections diagnosed clinically. The Institutional Ethics Committee approval was taken prior to the conduct of the study. Inclusion criteria included treatment naïve, clinically diagnosed cases of uncomplicated superficial bacterial skin infections. Complicated bacterial skin infections such as those requiring the systemic administration of antibiotics, i.e., those associated with lymphadenitis, signs and symptoms of systemic toxicity, extensive skin lesions, and localized deep infections of skin were excluded from the study. Patients with HIV infection, diabetes mellitus, or patients on corticosteroids therapy, were excluded from the study. Patients with known hypersensitivity to any of the study medication components, pregnant, and lactating women were excluded from the study. At the first visit after obtaining the relevant history, a thorough clinical examination was performed regarding the general condition of the patient, morphological features, distribution of lesions, and involvement of the lymph nodes. The diagnosis of the condition was confirmed clinically. Grading of the lesions was done with reference to parameters such as erythema, edema, vesiculation, pustulation, crusting, and scaling. Score was applied to each parameter as shown in [Table 1].
The patients were investigated to confirm the etiological agents by Gram staining and the associated conditions were ruled out. Systematic randomization of the patient was done so that thirty patients in each group received 2% mupirocin, 2% fusidic acid, and 1% nadifloxacin cream to be applied as a thin film thrice a day. Each patient was advised to follow general measures such as cleaning the affected part with warm water and drying before application of cold water compresses to remove crusts if any and maintenance of personal hygiene. Any other local or systemic antibiotic therapy was not permitted during the study period. The patient was followed up on the 4th day (follow-up visit 1), 8th day (follow-up visit 2), and 14th day (follow-up visit 3 or final visit) of the initiation of treatment. On each visit, grading of the lesions, checking the compliance of the patients, and any adverse reactions reported were recorded. On the final visit on the 14th day, grading of the lesions and final evaluation by the physician and patient was done. The evaluation was graded subjectively as clear, marked, moderate, slight improvement, or no change. Therapy was terminated in cases of serious adverse effects, failure to respond to therapy or to comply with protocol requirements, or development of an inter-current condition, which required discontinuation of the study medication and/or additional treatment. The results were subjected to analysis of variance test, followed by the Dunnett's test.
| Results|| |
Of the 90 patients, 30 patients in each arm completed the protocol defined treatment and follow-up. The baseline characteristics of the evaluable patient population are presented in [Table 2].
There were no statistically significant differences at the baseline between the groups with regards to the number of patients, age, sex, distribution, and duration of infection. A pretreatment bacteriological evaluation was possible in 27 of the 90 patients and the predominant organism on Gram staining comprised of Gram-positive cocci in 16/29 (59.2%) of cases. Nine patients showed Gram-negative organisms (33.3%). Majority of the patients were cases of primary uncomplicated bacterial skin infections comprising 67/90 (74.4%) cases and remaining 23/90 (25.5%) were cases of secondary uncomplicated bacterial skin infection.
Furuncle was the most common type of bacterial infection (59.70%), followed by folliculitis (4.4%) and secondarily infected scabies being the most common cause of secondary pyoderma 15 (65.21%).
Mupirocin, fusidic acid, and nadifloxacin; all showed a statistical significant improvement from the baseline scores at each visit as shown in [Table 3] and Graph 1. Fusidic acid showed faster reduction in scores at visit 1. However, the difference noted in the efficacy was not statistically significant. No side effects were noticed in any of the groups.
|Table 3: The Improvement in Total Score from Baseline to Final Visit with Respect to Each Drug|
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| Discussion|| |
Pyodermas are common in India and are caused largely by Staphylococcus aureus and occasionally by beta-hemolytic Streptococcus. Topical therapy is generally the preferred mode of administering antibiotics in their management for reasons of convenience and ease of application., Systemic therapy may be necessary only if the lesions are generalized if the regional lymph nodes are involved, if there is fever, and/or if the lesions are deep as in the case of erysipelas, deep folliculitis, cellulitis, and carbuncles. In order to be effective topically, an antibiotic must possess a broad antibacterial spectrum of action, have good penetration at the site of infection, good tissue tolerance, and show effective resolution of clinical signs and symptoms. It is also imperative for a topical antibiotic to penetrate the crusts thereby increasing the local bioavailability.
Topical 2% mupirocin and 2% fusidic acid are well-established in the treatment of uncomplicated bacterial skin infections. There is good evidence that topical mupirocin and topical fusidic acid are equally effective. They are more effective than oral treatment for people with limited disease. There have been reports of resistance to these topical antibiotics hence leading to problems in clinical cure., Studies recommend that resistance patterns against antibiotics must be taken into consideration in the choice of therapy. Nadifloxacin cream is a newer topical fluoroquinolone antibacterial compound with a benzoquinoline skeleton with fluorine at the sixth position and N-hydroxypiperidine at the eighth position. Fluoroquinolones act by inhibiting the formation of supercoiled DNA by DNA gyrase. It has broad-spectrum activity against Gram-positive bacteria, including coagulase-negative Staphylococcus species and Propionibacterium acnes granulosum, as has been demonstrated in previous in vitro infections. This agent is also very effective against Gram-negative bacteria including Pseudomonas aeruginosa and Escherichia coli in in vitro assays.
Our study documents that nadifloxacin too has a similar efficacy as the other two antibiotics. Review of literature and various drug regulatory authorities also approve this drug for acne vulgaris. In acne vulgaris, it has a mechanism of action similar to that of tetracyclines, which act directly as antioxidants against infiltrated neutrophils. The effects of nadifloxacin on neutrophils, including the generation of reactive oxygen species, chemotaxis, and phagocytosis were investigated. Nadifloxacin reduced the number of superoxide radical anions and hydroxyl radicals generated by neutrophils. These results indicate that the clinical effects of nadifloxacin may be partly due to its inhibitory action on the generation of superoxide and hydroxyl radicals by neutrophils leading to the reduction in oxidative tissue injury. However, among all the three drugs, fusidic acid was found to be the most economical.
The limitations of this study were relatively lesser sample size, lack of facilities for complete microbiological analysis of the infecting bacteria with culture, in vitro sensitivity, and determination of minimum inhibitory concentration values. Follow-up studies for recurrence of the lesions at the same site could not be performed. We suggest more double-blinded and multicentric studies with larger population size to corroborate our results.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Mehta SM, Garg BR, Kanungo R. A clinica-bacteriological study of primary uncomplicated bacterial skin infections of children in Pondicherry. Indian J Dermatol Venereol Leprol 1992;58:183-7.
Mehta TK. Pattern of skin disease in India. Indian J Dermatol Venereol Leprol 1962;28:134-9.
George A, Rubin G. A systematic review and meta-analysis of treatments for impetigo. Br J Gen Pract 2003;53:480-7.
Korting HC. Differences in the skin surface pH and bacterial microflora due to the long-term application of synthetic detergent preparations of pH 5.5 and pH 7.0. Results of a crossover trial in healthy volunteers. Acta Derm Venereol 1990;70:429.
Oberai C, Shailendra S, Dalal D, Patil DJ, Patil R, Umrigar D, et al.
A comparative clinical study of sisomicin cream versus mupirocin ointment in pyodermas. Indian J Dermatol Venereol Leprol 2002;68:78-81.
Saunders WE. AMA Drug Evaluations: Topical Anti-infective Agents. Philadelphia; 1986. p. 1503.
Leyden JJ, Kligman AM. Rationale for topical antibiotics. Cutis 1978;22:515-20, 522-8.
Pasricha JS, Gupta R. Pyodermas. In: Textbook of Dermatology. Delhi: Jaypee; 1999. p. 28.
Koning S, van der Sande R, Verhagen AP, van Suijlekom-Smit LWA, Morris AD, Butler CC, Berger M, van der Wouden JC. Interventions for impetigo. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD003261. DOI: 10.1002/14651858.CD003261.pub3.
Jacobs MR, Appelbaum PC. Nadifloxacin: A quinolone for topical treatment of skin infections and potential for systemic use of its active isomer, WCK 771. Expert Opin Pharmacother 2006;7:1957-66.
[Table 1], [Table 2], [Table 3]