Clinical Trial: Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

Brief Summary: An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.

Detailed Summary:
Sponsor: LEO Pharma

Current Primary Outcome: Clinical cure at end of treatment according to investigator's assessment [ Time Frame: End of treatment ]

Investigator's assessment of severity of infections (SIRS).

  • Exudates/pus
  • Crusting
  • Erythema
  • Oedema
  • Tissue Warmth
  • Itching
  • Pain


Original Primary Outcome: Clinical cure at end of treatment according to invstigator's assessment [ Time Frame: End of treatment ]

Current Secondary Outcome: Clinical cure at follow-up according to investigator's assessment. Clinical cure at end of treatment and follow-up according to investigator's assessment. Bacteriological cure at end of treatment and follow-up. [ Time Frame: At Visit 2, at follow up, at end of treatment ]

Investigator's assessment of severity of infections (SIRS).

  • Exudates/pus
  • Crusting
  • Erythema
  • Oedema
  • Tissue Warmth
  • Itching
  • Pain

Clinical cure will be either of the following:

  • Total absence of signs and symptoms of impetigo/SITL or
  • Improvement - total SIRS score reduced to <8 and all individual clinical signs/symptoms included in the SIRS score should be ≤ 4

Bacteriological cure will be:

  • Documented eradication
  • Presumed eradication
  • Documented infection with a pathogen different from the baseline pathogen, and the pateient is NOT symptomatic.


Original Secondary Outcome: Clinical cure at follow-up according to investigator's assessment. Clinical cure at end of treatment and follow-up according to investigator's assessment. Bacteriological cure at end of treatment, follow-up, and end of treatment and follow-up according [ Time Frame: At Visit 2, at follow up, at end of treatment ]

Information By: LEO Pharma

Dates:
Date Received: February 21, 2008
Date Started: February 2008
Date Completion:
Last Updated: November 22, 2013
Last Verified: November 2013