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Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)
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.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 773 |
| Start date | 2008-02 |
| Completion | 2009-06 |
Conditions
- Impetigo
- Secondarily Infected Traumatic Lesions
Interventions
- TD1414 2% cream
- TD1414 2% cream
- Bactroban® (mupirocin) 2% cream
Primary outcomes
- Participants With Clinical Cure According to Investigator's Assessment — At end of treatment (Day 8)
At end of treatment (Day 8), the participants had their impetigo/Secondarily Infected Traumatic Lesions (SITL) evaluated by the (sub)investigator. Investigator's assessment of severity of infections (SIRS). * Exudates/pus * Crusting * Erythema * Oedema * Tissue Warmth * Itching * Pain Each sign/symptoms of infection was assessed by use of the following 4-point scale: * 0 = absent * 2 = mild * 4 = moderate * 6 = severe The scores were summed up to a total SIRS score. Clinical cure was 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 have been ≤4. Clinical failure was either of the following: * Signs and symptoms of impetigo/SITL that did not meet the definition of clinical cure * Unable to determine (e.g. participants who refuse clinical examination or did not show at end of treatment or follow-up).
Countries
United States, South Africa