Last updated: 11/07/2018 13:34:40
A Double-Blind, Double-Dummy, Randomized Trial to Compare the Safety and Efficacy of Topical SB275833 BID for 10 days vs. Oral Cephalexin BID for 10 days in subjects with Secondarily Traumatic Infected Lesions.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Double-Blind, Double-Dummy, Randomized Trial to Compare the Safety and Efficacy of Topical SB275833 BID for 10 days vs. Oral Cephalexin BID for 10 days in subjects with Secondarily Traumatic Infected Lesions.
Trial description: A Double-Blind, Double-Dummy, Randomized Trial to Compare the Safety and Efficacy of Topical SB275833 BID for 10 days vs. Oral Cephalexin BID for 10 days in subjects with Secondarily Traumatic Infected Lesions.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Almena Free, MD Eli Roth, MD Marybeth Dalessandro, BS Joseph Hirman, PhD Nicole Scangarella, MS Ribhi Shawar, PhD Scott White, MD on behalf of the SB275833/030 study group . Retapamulin Ointment, 1%, Twice Daily for 5 Days versus Oral Cephalexin Twice Daily for 10 Days in the Treatment of Uncomplicated Secondarily Infected Cutaneous Skin Lesions due to Trauma. Skinmed. 2006;5(5):224-232.
Dalessandro M et al.. Efficacy and safety of topical Retapamulin ointment, 1%, w/w, twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily-infected traumatic lesions: results of a randomized, controlled trial. Clin. Infect. Dis.. December 2006;
Nicole E Scangarella, Ribhi M Shawar, S Bouchillon, D Hoban. The microbiological profile of a new topical antibacterial, retapamulin ointment, 1% . Expert Rev Anti Infect Ther. 2009;7(3):269-279.
Medical condition
Skin Diseases, Bacterial
Product
retapamulin
Collaborators
Not applicable
Study date(s)
May 2004 to April 2005
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-05-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website