Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. (NCT00555061) | Clinical Trial Compass
CompletedPhase 4
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
United States60 participantsStarted 2007-09
Plain-language summary
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
Who can participate
Age range2 Months – 24 Months
SexALL
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Inclusion criteria:
* Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
* Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:
The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.
The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.
Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.
* Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)
* Protocol Compliance: The parent/legal guardian is willing to comply with…
What they're measuring
1
Number of Participants With Measurable Plasma Concentrations, by Age Group
Timeframe: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day