ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) (ALTARGOPMS)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 21, 2011
Last updated: September 21, 2015
Last verified: September 2015
This is an open label, multi-centre, non-interventional post-marketing surveillance.

Condition Intervention
Skin Infections, Bacterial
Drug: ALTARGO(retapamulin)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Efficacy of ALTARGO(Retapamulin) Administered in Korean Patients According to the Prescribing Information

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of unexpected adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • The number of serious adverse event after ALTARGO(retapamulin) treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Effectiveness of ALTARGO(retapamulin) treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 3612
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The subjects with bacterial skin and skin structure infections (SSSI)
Drug: ALTARGO(retapamulin)
Basically there is no treatment allocation. Subjects who would be administered of ALTARGO(retapamulin) at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Detailed Description:

This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ALTARGO(retapamulin) treated in Korean patients according to the prescribing information.

ALTARGO is a trademark of the GlaxoSmithKline group of companies.


Ages Eligible for Study:   9 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated ALTARGO(retapamulin) with primary impetigo or secondarily infected traumatic lesions in Korea

Inclusion Criteria:

  • All subjects must satisfy the following criteria at study entry:

    1. Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI)
    2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
    3. Subjects administered with ALTARGO(retapamulin) following the locally approved prescribing information

Exclusion Criteria:

  • Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved Prescribing Information.

    1. Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment
    2. Infants under nine months of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01445600

Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01445600     History of Changes
Other Study ID Numbers: 115579 
Study First Received: September 21, 2011
Last Updated: September 21, 2015
Health Authority: Korea: MFDS(Ministry of Food and Drug Safety)

Keywords provided by GlaxoSmithKline:
secondarily-infected traumatic lesions

Additional relevant MeSH terms:
Bacterial Infections
Skin Diseases, Infectious
Skin Diseases processed this record on May 26, 2016