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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Skin Infections, Bacterial

Treatments: Drug: ALTARGO(retapamulin)

Study type: Observational

Funder types: Industry

Identifiers

NCT01445600

115579

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,612 patients

Sex: All

Ages: 9+ months old

Volunteers: No 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

Trial design

3,612 participants in 1 patient group

ALTARGO(retapamulin)

Description:

The subjects with bacterial skin and skin structure infections (SSSI)

Treatment:

Drug: ALTARGO(retapamulin)