Generic selectors
Exact matches only
Search in title
Search in content
Search in posts
Search in pages
Filter by Categories
15th National Conference of the IAOMFP, Chennai, 2006
Abstract
Abstracts from current literature
Acne in India: Guidelines for management - IAA Consensus Document
Addendum
Announcement
Art & Psychiatry
Article
Articles
Association Activities
Association Notes
Award Article
Book Review
Brief Report
Case Analysis
Case Letter
Case Letters
Case Notes
Case Report
Case Reports
Clinical and Laboratory Investigations
Clinical Article
Clinical Studies
Clinical Study
Commentary
Conference Oration
Conference Summary
Continuing Medical Education
Correspondence
Corrigendum
Cosmetic Dermatology
Cosmetology
Current Best Evidence
Current View
Derma Quest
Dermato Surgery
Dermatopathology
Dermatosurgery Specials
Dispensing Pearl
Do you know?
Drug Dialogues
e-IJDVL
Editor Speaks
Editorial
Editorial Remarks
Editorial Report
Editorial Report - 2007
Editorial report for 2004-2005
Errata
Erratum
Focus
Fourth All India Conference Programme
From Our Book Shelf
From the Desk of Chief Editor
General
Get Set for Net
Get set for the net
Guest Article
Guest Editorial
History
How I Manage?
IADVL Announcement
IADVL Announcements
IJDVL Awards
IJDVL AWARDS 2015
IJDVL Awards 2018
IJDVL Awards 2019
IJDVL Awards 2020
IJDVL International Awards 2018
Images in Clinical Practice
In Memorium
Inaugural Address
Index
Knowledge From World Contemporaries
Leprosy Section
Letter in Response to Previous Publication
Letter to Editor
Letter to the Editor
Letter to the Editor - Case Letter
Letter to the Editor - Letter in Response to Published Article
LETTER TO THE EDITOR - LETTERS IN RESPONSE TO PUBLISHED ARTICLES
Letter to the Editor - Observation Letter
Letter to the Editor - Study Letter
Letter to the Editor - Therapy Letter
Letter to the Editor: Articles in Response to Previously Published Articles
Letters in Response to Previous Publication
Letters to the Editor
Letters to the Editor - Letter in Response to Previously Published Articles
Letters to the Editor: Case Letters
Letters to the Editor: Letters in Response to Previously Published Articles
Medicolegal Window
Messages
Miscellaneous Letter
Musings
Net Case
Net case report
Net Image
Net Letter
Net Quiz
Net Study
New Preparations
News
News & Views
Obituary
Observation Letter
Observation Letters
Oration
Original Article
ORIGINAL CONTRIBUTION
Original Contributions
Pattern of Skin Diseases
Pearls
Pediatric Dermatology
Pediatric Rounds
Perspective
Presedential Address
Presidential Address
Presidents Remarks
Quiz
Recommendations
Regret
Report
Report of chief editor
Report of Hon : Treasurer IADVL
Report of Hon. General Secretary IADVL
Research Methdology
Research Methodology
Resident page
Resident's Page
Resident’s Page
Residents' Corner
Residents' Corner
Residents' Page
Retraction
Review
Review Article
Review Articles
Revision Corner
Self Assessment Programme
SEMINAR
Seminar: Chronic Arsenicosis in India
Seminar: HIV Infection
Short Communication
Short Communications
Short Report
Special Article
Specialty Interface
Studies
Study Letter
Supplement-Photoprotection
Supplement-Psoriasis
Symposium - Contact Dermatitis
Symposium - Lasers
Symposium - Pediatric Dermatoses
Symposium - Psoriasis
Symposium - Vesicobullous Disorders
SYMPOSIUM - VITILIGO
Symposium Aesthetic Surgery
Symposium Dermatopathology
Symposium-Hair Disorders
Symposium-Nails Part I
Symposium-Nails-Part II
Tables
Technology
Therapeutic Guidelines
Therapeutic Guidelines - IADVL
Therapeutics
Therapy
Therapy Letter
View Point
Viewpoint
What’s new in Dermatology
Original Article
2002:68:2;78-81
PMID: 17656883

A comparative clinical study of sisomicin cream versus mupirocin ointment in pyodermas

Chetan Oberai1 , S Shailendra2 , Darchan Dalal3 , DJ Patil3 , Rajshri Patil3 , Deepak Umrigar3 , Sandip Chowdhury3
1 Dept. of Skin, STD & Leprosy, Grant Medical College & Sir J. J. Group of Hospitals J. J. Road, Byculla, Mumbai, India
2 BJ Medical College Pune, India
3 Government Medical College, New Civil Hospital, Surat, India

Correspondence Address:
Chetan Oberai
Dept. of Skin, STD & Leprosy, Grant Medical College & Sir J. J. Group of Hospitals J. J. Road, Byculla, Mumbai
India
How to cite this article:
Oberai C, Shailendra S, Dalal D, Patil D J, Patil R, Umrigar D, Chowdhury S. A comparative clinical study of sisomicin cream versus mupirocin ointment in pyodermas. Indian J Dermatol Venereol Leprol 2002;68:78-81
Copyright: (C)2002 Indian Journal of Dermatology, Venereology, and Leprology

Abstract

This study was designed to compare the efficacy and safety of sisomicin cream (0.1%) or mupirocin ointment (2%) in the treatment of primary or secondary pyodermas requiring topical antibiotic therapy alone. In the evaluable patients (n=290), impetigo was the commonest clinical condition reported. Staphylococcus aureus was the commonest pathogen isolated from the lesons. Both sisomicin and mupirocin treatments produced a steady improvement in the scores of erythema, oedema, vesiculation, pustulation, crusting and scaling but the improvement produced by sisomicin was quicker and more pronounced. The percentage of patients with complete clearing of all lesions was also higher with sisomicin than with mupirocin on days 4, 8 and 14. Patients subjectively rated the sisomicin formulation as excellent in 75% of cases as against 59% with mupirocin. Sisomicin and mupirocin are effective and safe in the management of pyodermas; however sisomicin therapy resulted in faster and greater relief of signs and symptoms.
Keywords: Mupirocin, Pyoderma, Sisomicin

Introduction

Topical anti-infective therapy is commonly employed for the treatment of pyodermas, which are caused predominantly by gram positive cocci. Sisomicin, a member of the aminoglycoside group of antibiotics, with established efficacy and safety[1] enjoys wide usage in India, while mupirocin is a newer topical antibiotic, effective primarily against gram positive cocci.[2] A review of the literature did not reveal any study comparing these two agents. The present study was therefore aimed at comparing their safety and efficacy in pyodermas.

Subjects and Methods

This was a prospective, randomised, parallel-group multicetric study that enlisted patients presenting with pyodermas requiring topical antibiotic therapy alone. The exclusion criteria were hypersensitivity to either sisomicin or mupirocin; any significant medical condition that in the judgement of the investigator might interfere with the study conduct; pregnancy and lactation. Eligible patients were assigned to treatment with either sisomicin or mupirocin based on a predesigned randomization schedule. Treatment with topical sisomicin cream (0.1%) twice a day, or mupirocin ointment (2%) thrice a day was given for a minimum of 7 and up to a maximum of 14 days. It was continued for at least 48 hours after the patients became asymptomatic. Therapy was terminated in cases of serious adverse effects, failure to respond to therapy or to comply with protocol requirements, or development of an intercurrent condition, which required discontinuation of the study medication and/or additional treatment. Patients were not allowed to take any other antibiotic (systemic or local) during the study.

At the time of enrollment, a written informed consent and a complete medical history was obtained and a thorough physical examination carried out. Six clinical parameters, viz. erythema, oedema, vesiculation, pustulation, cursting and scaling were evaluated using a 4-point grading system (0=none; not noticed by the physician or patient; 1=mild; noticed by the physician and/or patient, but not disturbing to the patient; 2=moderate; parameter definitely present and disturbing to the patient and interferes with some activity and/or sleep; 3 =severe; parameter very marked and very disturbing, interfering with most activities and/or sleep). Evaluation was done at baseline and days 4, 8 and 14. Efficacy of therapy was evaluated on the basis of reduction in the mean symptom scores at each follow up visit.

A pretreatment bacteriological examination of the lesion was performed to identify the causative pathogen and its sensitivity pattern in vitro. After completion of therapy, if a culture source was available, a post-treatment bacteriological evaluation was also done. The overall bacteriological response to therapy was classified as follows: elimination=causative organism absent at or immediately after termination of therapy, or the complete disappearance of the culture source so that follow-up culture is not possible; persistence=continued presence of causative organism at the end of treatment; reinfection =isolation of a new pathogen in any culture obtained in post-treatment period.

At the end of the study period for each individual patient, the investigator evaluated the response to therapy as follows: clear / marked improvement / moderate improvement / slight improvement / no change. The patient′s evaluation of the formulation was recorded as excellent/good/ fair. Adverse experiences, if any, were recorded with the date and time of onset, duration and severity (mild, moderate, severe) and the relationship to the study drug (unrelated, possible, probable and definite).

Statistical Analysis

Data was analysed at the end of the trial process. Demographic variables such as age, weight and sex were summarized. Bacterial elimination rate and clinical cure rate was compared statistically, using chi-squared (R2) test. The data measured on a continuous scale was compared using Students test. AP value v< 0.05 was considered significant.

Results

290 patients i.e. 147 on the sisomicin arm and 143 on the mupirocin arm, completed protocol-defined treatment and follow-up. There was no statistically significant difference between the two groups with regard to the number of patients, age and sex distribution or duration of infection. A pre-treatment bacteriological evaluation was possible in 132 patients on the sisomicin arm and 129 patients in the mupirocin arm. Both the groups were matched in the distribution of clinical conditions with impetigo being the commonest condition followed by folliculitis [Table - 1].

There was a progressive decline in the scores of erythema in both the groups, but the improvement was significantly more marked in the sisomicin group than that in the mupirocin group on days 4,8 and 14 [Figure - 1]. Sisomicin treatment also produced a greater improvement in the oedema scores than mupirocin, the difference being statistically significant on days 4 and 8 [Figure - 2].

The scores of vesiculation, pustulation and crusting all showed a steady improvement with treatment in both the groups, but the improvement with sisomicin was uniformly more marked than that with mupirocin; this difference was statistically significant at one or more time point [Figure - 3], [Figure - 4], [Figure - 5], [Figure - 6].

The reduction in the total mean score (for all evaluable clinical parameters) in the sisomicin arm vis-a-vis the reduction in the mupirocin arm was statistically significant on all days of followup. i.e. the improvement obtained with sisomicin treatment was statistically significant at all time points of follow up [Figure - 7].

The number of lesions showing complete clearance as evaluated by the attending doctor improved steadily with time in both the groups, with sisomicin leading to a more marked rate of clearance than mupirocin [Figure - 8].

Patients′ subjective evaluation which then used indicated a strong preference for sisomicin cream: 75% of the patients in the sisomicin arm rated the formulation as "excellent" compared to only 59% of the patients in the mupirocin arm (p< 0.001).

Staphylococcus aureus was isolated in whom a pre-treatment culture was positive (n=132 in sisomicin group and n=129 in mupirocin group). In addition to S. aureus, Streptococcus pyogenes was cultured in 39 patients in the sisomicin group and 34 patients in the mupirocin group. The bacteriological elimination rate was 97% with sisomicin therapy as against 94% with mupirocin.

No side effects were reported in either group.

Discussion

Pyodermas are common in India and are caused largely by Staphylococcus aureus and occasionally group a Beta-hemolytic streptococci. Topical therapy is generally the preferred mode of administering antibiotics in their management for reasons of convenience and ease of application.[3],[4] Systemic therapy may be necessary only if the lesions are generalised, 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.[5]

In order to be effective topically, an antibiotic must possess a broad antibacterial spectrum of action, good penetration to the site of infection, good tissue tolerance and effective resolution of clinical signs and symptoms. Sisomicin′s in vitro efficacy against a wide range of gram-positive and gram-negative clinical isolates, including gentamicin-resistant Pseudomonas aeruginosa, has been well established.[6] Its efficacy has also been documented in the management of superficial infections of skin and skin structures in Indian conditions.[7] Mupirocin is a newer topical antibiotic with food activity against gram-positive pathogens that is indicated for the treatment of infective dermatoses like imperigo.[8],[9] However the development of resistance to this agent is posing a challenge to infection control and antibiotic prescribing practice throughout the world.[10]

The present randomized study confirms the efficacy and safety of sisomicin and mupirocin in patients presenting with a variety of primary and secondary pyodermas. An important finding of this study was the greater and faster improvement of all evaluated clinical parameters with sisomicin as compared to mupirocin, which was statistically significant on all days of follow-up. This was reflected in the fact that a greater number of lesions in patients treated with sisomicin showed complete clearing on all days of follow-up. Also, a significantly greater number of patients rated sisomicin cream as an excellent formulation compared to mupirocin ointment.

Based on the findings of the present study, it may be concluded that sisomicin and mupirocin are safe and effective antibiotics in the management of pyodermas and that sisomicin offers advantages over mupirocin in terms of the faster and greater relief of various signs and symptoms.

References
1.
Deshpande SG. Sisomicin cream vs Neosporin ointment in primary pyodermos. Indian J Dermatol Veneorol Leprol 1991;36:40-46.
[Google Scholar]
2.
Wise R, Hohnson J. Mupirocin resistance. Lancet 1991;338:578.
[Google Scholar]
3.
Saunders WE. AMA Drug Evaluations: Topical anti-infective agents. Philadelphia, 1986;1503.
[Google Scholar]
4.
Leyden JJ, Kligman AM. Rationale for topical antibiotics. Cutis 1987;22:515-528.
[Google Scholar]
5.
Pasricha JS, Gupta R. Pyodermas. In: Textbook of Dermatology. Delhi: laypee, 1999;28.
[Google Scholar]
6.
Lakshmi A, Kumar AG. In vitro comparative activity of kanamycin, gentamicin and sisomicin-a new aminoglycoside, against clinical isolates. Indian J Pathol Microbial 1989;32:207-212.
[Google Scholar]
7.
Thomas J, Parimalam S, Prabhavathy D, et al. A study of topical sisomicin sulphate in folliculitis. The Antiseptic 1990;87:339-340.
[Google Scholar]
8.
Lamb YJ. Overview of the role of mupirocin. J Hosp Infect 1991;19(Suppl B):27-30.
[Google Scholar]
9.
Leyden JJ. Review of mupirocin ointment in the treatment of impetigo. Clin Ped 1992;31:549-533.
[Google Scholar]
10.
Cookson BD. The emergence of mupirocin resistance: a challenge to infection control and antibiotic prescribing practice. J Antimicrob Chemother 1998;41:11-18.
[Google Scholar]
Show Sections