Secondarily-Infected Dermatoses MedDRA version: 7.0 Level: PT Classification code 10012470
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject is ? 13 years of age. 2. The subject and/or parent/legal guardian has given written informed, dated consent to participate in the study. 3. The subject has a diagnosis of atopic dermatitis, psoriasis or allergic contact dermatitis. 4. The subject has one or more of the following clinical signs and symptoms of secondary infection: a sudden exacerbation of the underlying dermatosis, crusting, weeping, small superficial pustules, or purulent discharge. 5. The subject has a secondarily infected dermatosis which is suitable for treatment with oral or topical antibacterial therapy. 6. The infected lesion/lesions is/are ? 100 cm2 in area, or up to a maximum of 2% body surface area for subjects =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. The subject has demonstrated a previous hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactam antibiotics, or the subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure [GlaxoSmithKline Document Number UM2003/00089/00] for composition of 1% SB-275833 ointment). 2. The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent. 3. 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). 4. The subject requires surgical intervention, such as incision and drainage, for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study. 5. The subject has received one or more days of treatment with a systemic and/or topical antibacterial within 72 hours of study entry. 6. The subject is receiving systemic corticosteroids at a dose of >10mg per day of prednisone (or the equivalent). 7. The subject is receiving concomitant renal tubular secretion inhibitors (e.g., probenecid). 8. The subject has a serious underlying disease that could be imminently life-threatening. 9. The subject is pregnant, breast feeding or planning a pregnancy during the study, or of childbearing potential or less than one year post-menopausal and not using an accepted method of contraception (i.e., surgical sterilization, intra-uterine contraceptive device, oral contraception plus barrier contraception, other hormone delivery systems plus barrier contraception, diaphragm or condom in combination with contraceptive cream, jelly or foam) . 10. The subject has used an investigational drug within 30 days prior to entering the study. 11. The subject has been previously enrolled in this study or in any other study involving SB-275833.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that topical 1% SB-275833 ointment, applied twice daily for 5 days, is at least as effective clinically as oral cephalexin, 500mg in adults, or 12.5mg/kg in children, twice daily for 10 days, in the treatment of secondarily-infected dermatoses, including atopic dermatitis, psoriasis and allergic contact dermatitis;Secondary Objective: The secondary objective of this study is to evaluate the bacteriological efficacy and safety of topical 1% SB-275833 ointment, applied twice daily for 5 days and oral cephalexin, 500mg in adults, or 12.5mg/kg in children, twice daily for 10 days, in the treatment of secondarily-infected dermatoses;Primary end point(s): Clinical response at follow-up (7-9 days post-therapy; day 12-14 for 1% SB-275833 ointment and day 17-19 for cephalexin) The hypothesis to be tested by the primary endpoint is that the clinical efficacy at follow-up of 1% SB-275833 ointment b.i.d. in the treatment of subjects with SID is non-inferior to subjects treated with cephalexin | — |
Countries
Austria, Italy
Outcome results
None listed