Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections

Benjamin R. Bohaty, Sangbum Choi, Chunyan Cai, Adelaide A. Hebert

Research output: Contribution to journalArticle

Abstract

Background: Cutaneous bacterial infections are common in children and adults and frequently are caused by Staphylococcus aureus (S. aureus). Treatment failures with topical agents are not uncommon and have been shown to be secondary to bacterial resistance. Objective: To determine clinical and bacteriological efficacy of retapamulin ointment 1% in treatment of patients with cutaneous bacterial infections caused by methicillin-resistant S. aureus (MRSA) and other bacteria. Methods: Prospective, nonrandomized, uncontrolled, open label, single center trial conducted between April 2008 and November 2012 that evaluated efficacy of retapamulin ointment 1% in the treatment of impetigo, folliculitis, and other minor soft tissue infections in children and adults. Fifty patients, who presented to a dermatology outpatient clinic and were clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic, were screened. Thirty-eight patients were enrolled and received treatment: topical retapamulin ointment 1% twice daily for 5 days. Seven patients were MRSA positive and qualified for the primary efficacy population. One patient withdrew due to an adverse event. Clinical and microbiological exams were performed at baseline and follow-up 5 to 7 days later to assess clinical, microbiological, and therapeutic responses. Primary outcome was clinical response at follow-up in primary efficacy population with MRSA isolated as the baseline pathogen. Secondary outcomes included clinical, microbiologic, and therapeutic responses in patients who were culture positive for any species of bacteria. Results: Clinical response at follow-up in the primary efficacy population (MRSA-positive patients) was not sufficiently powered to demonstrate significance; however, outcomes were excellent, with 7 of 7 patients demonstrating clinical success (5 of 7) or clinical improvement (2 of 7) at follow-up. Barring lack of significance due to small total sample size for patients who were culture positive for any species of bacteria (n = 35), overall success rates were favorable for clinical, microbiologic, and therapeutic responses with values of 66%, 97%, and 69%, respectively. Adverse events (AEs) were mild or moderate in severity. No serious AEs were reported. Conclusion: Safety profile appears favorable given the low number of AEs. Study design limits conclusions that can be drawn. Nevertheless, this study supports use of topical retapamulin 1% ointment in treatment of cutaneous bacterial infections, particularly those caused by S. aureus, including MRSA.

Original languageEnglish
Pages (from-to)13-20
Number of pages8
JournalInternational Journal of Women's Dermatology
Volume1
Issue number1
DOIs
Publication statusPublished - 2015 Jan 1
Externally publishedYes

Fingerprint

Impetigo
Ointments
Skin
Methicillin-Resistant Staphylococcus aureus
Infection
Bacterial Infections
Folliculitis
Soft Tissue Infections
Therapeutics
Bacteria
Staphylococcus aureus
Population
retapamulin
Dermatology
Ambulatory Care Facilities
Treatment Failure
Sample Size
Anti-Bacterial Agents
Safety

Keywords

  • Impetigo
  • MRSA
  • MSSA
  • Pediatric
  • Retapamulin

ASJC Scopus subject areas

  • Dermatology

Cite this

Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. / Bohaty, Benjamin R.; Choi, Sangbum; Cai, Chunyan; Hebert, Adelaide A.

In: International Journal of Women's Dermatology, Vol. 1, No. 1, 01.01.2015, p. 13-20.

Research output: Contribution to journalArticle

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abstract = "Background: Cutaneous bacterial infections are common in children and adults and frequently are caused by Staphylococcus aureus (S. aureus). Treatment failures with topical agents are not uncommon and have been shown to be secondary to bacterial resistance. Objective: To determine clinical and bacteriological efficacy of retapamulin ointment 1{\%} in treatment of patients with cutaneous bacterial infections caused by methicillin-resistant S. aureus (MRSA) and other bacteria. Methods: Prospective, nonrandomized, uncontrolled, open label, single center trial conducted between April 2008 and November 2012 that evaluated efficacy of retapamulin ointment 1{\%} in the treatment of impetigo, folliculitis, and other minor soft tissue infections in children and adults. Fifty patients, who presented to a dermatology outpatient clinic and were clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic, were screened. Thirty-eight patients were enrolled and received treatment: topical retapamulin ointment 1{\%} twice daily for 5 days. Seven patients were MRSA positive and qualified for the primary efficacy population. One patient withdrew due to an adverse event. Clinical and microbiological exams were performed at baseline and follow-up 5 to 7 days later to assess clinical, microbiological, and therapeutic responses. Primary outcome was clinical response at follow-up in primary efficacy population with MRSA isolated as the baseline pathogen. Secondary outcomes included clinical, microbiologic, and therapeutic responses in patients who were culture positive for any species of bacteria. Results: Clinical response at follow-up in the primary efficacy population (MRSA-positive patients) was not sufficiently powered to demonstrate significance; however, outcomes were excellent, with 7 of 7 patients demonstrating clinical success (5 of 7) or clinical improvement (2 of 7) at follow-up. Barring lack of significance due to small total sample size for patients who were culture positive for any species of bacteria (n = 35), overall success rates were favorable for clinical, microbiologic, and therapeutic responses with values of 66{\%}, 97{\%}, and 69{\%}, respectively. Adverse events (AEs) were mild or moderate in severity. No serious AEs were reported. Conclusion: Safety profile appears favorable given the low number of AEs. Study design limits conclusions that can be drawn. Nevertheless, this study supports use of topical retapamulin 1{\%} ointment in treatment of cutaneous bacterial infections, particularly those caused by S. aureus, including MRSA.",
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