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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00626795 |
An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.
Condition | Intervention | Phase |
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Impetigo Secondarily Infected Traumatic Lesions |
Drug: Bactroban® (mupirocin) 2% Cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy, Safety and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL) |
Estimated Enrollment: | 664 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne-Marie R Larsen, DVM | +4544945888 | anne-marie.larsen@leo-pharma.com |
Contact: Birgitte Vestbjerg | +4544945888 | birgitte.vestbjerg@leo-pharma.com |
United States, Alabama | |
Anniston Medical Clinic | Recruiting |
Anniston, Alabama, United States, 36207 | |
Contact: Almena L Free, MD 256-236-5361 | |
Principal Investigator: Almena L Free, MD |
Principal Investigator: | Almena L Free, MD | Anniston Medical Clinic |
Responsible Party: | LEO Pharma A/S ( Anne-Marie R. Larsen / International Clinical Trial Manager ) |
Study ID Numbers: | TD1414-C21 |
Study First Received: | February 21, 2008 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00626795 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Skin Diseases, Infectious Mupirocin |
Skin Diseases Streptococcal Infections Skin Diseases, Bacterial Staphylococcal Skin Infections Impetigo |
Infection |