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

• Conditions: Secondarily-Infected Dermatoses; MedDRA version: 7.0Level: PTClassification code 10012470

• Registration Number: EUCTR2004-000784-97-AT
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-01
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 808

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 < 18 years of age.
7. The subject has a Skin Infection Rating Scale score of at least 8 (see Appendix A).
8. The subject has had a negative urine pregnancy test prior to enrollment (if of childbearing potential).
9. The subject is willing and able to comply with the study protocol.
Additional Pediatric Inclusion Criteria (pending IDMC review of Studies 275833/030A and 275833/030B):
10. The subject is ? 9 months of age.
11. The parent/legal guardian is willing to comply with the protocol.
12. The parent/legal guardian has given written informed, dated consent for the subject to participate in the study

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified