ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01445600

Acronym

ALTARGOPMS

Enrollment

3612

Registered

2011-10-04

Start date

2012-11-30

Completion date

2015-08-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Infections, Bacterial

Keywords

Impetigo, secondarily-infected traumatic lesions, retapamulin

Brief summary

This is an open label, multi-centre, non-interventional post-marketing surveillance.

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.

Interventions

DRUGALTARGO(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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The number of adverse event after ALTARGO(retapamulin) treatment	14 days

Secondary

Measure	Time frame
The number of unexpected adverse event after ALTARGO(retapamulin) treatment	14 days
The number of serious adverse event after ALTARGO(retapamulin) treatment	14 days
Effectiveness of ALTARGO(retapamulin) treatment	7 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026