A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• The subject is> 13 years old
• The subject and / or his / her legal parent (s) / guardian (s) have given written informed consent dated to participate in the study.
• The subject has a diagnosis of atopic dermatitis, psoriasis or allergic contact dermatitis.
• The subject has one or more of the following clinical signs and symptoms of secondary infection: a sudden exacerbation of the underlying dermatosis, crusting, secretion, small superficial pustules, or purulent discharge.
• Subject has a secondarily infected dermatosis, which is appropriate for treatment with oral or topical antibacterial therapy.
• Infected lesions / lesions have <100 cm of area, or up to 2% of body body area in subjects <18 years of age.
• The subject has a score on the Scale to Qualify Skin Infection Rating (Scale) of at least 8.
• The subject has had a urine test to diagnose the negative pregnancy before recruitment (if it has potential to have a family).
• The subject wants and is able to comply with the study protocol.

Exclusion Criteria

• The subject has shown prior hypersensitivity to penicillins, cephalosporins, or other p-lactam antibiotics, or the subject has demonstrated a prior hypersensitivity reaction to pleuromutilin or any component of the ointment
• The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent.
• The subject has systemic signs and symptoms of infection (such as fever, defined as an oral temperature greater than 101 ° F or 38.3 ° C).
• The subject requires a surgical intervention, such as incision and drainage, to treat the infection prior to enrolling in the study, or is likely to require such intervention during the course of the study.
• The subject has received one or more days of treatment with a systemic or topical antibacterial agent within 72 hours of entering the study.
• The subject is receiving systemic corticosteroids at a dose> 10 mg per day of prednisone (or its equivalent).
• The subject is concomitantly receiving inhibitors of renal tubular secretion (eg, probenecid).
• The subject has a serious underlying disease that could be imminently potentially lethal.
• The subject is pregnant, breastfeeding or planning to become pregnant during the study, or has the potential to have a family or is less than one year after menopause and is not using an accepted method of contraception (eg, surgical sterilization, contraceptive device) intrauterine, oral contraception plus barrier contraception, other hormone delivery systems plus barrier contraception, diaphragm or condom in combination with a contraceptive cream, gel or foam)
• The subject has used some research drug for 30 days before entering the study.
• The subject has been previously enrolled in the present study or in another study involving SB-275833.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation of signs and symptoms<br>Measure:Clinical response in the follow-up<br>Timepoints:7 to 9 days after the therapy; days 12 to 14 for SB-275833 in 1% ointment and days 17 to 19 for cephalexin<br>

Secondary Outcome Measures

Name	Time	Method

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