Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01126268
First received: April 19, 2010
Last updated: January 20, 2016
Last verified: January 2016
Results First Received: December 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Impetigo
Folliculitis
Secondarily Infected Eczema
Minor Soft Tissue Infections
Intervention: Drug: Retapamulin (Altabax)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Retapamulin Ointment 1% Group Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.

Participant Flow:   Overall Study
    Retapamulin Ointment 1% Group  
STARTED     38  
COMPLETED     37  
NOT COMPLETED     1  
Adverse Event                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Retapamulin Ointment 1% Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days

Baseline Measures
    Retapamulin Ointment 1%  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     28  
Between 18 and 65 years     6  
>=65 years     4  
Age  
[units: years]
Mean (Standard Deviation)
  18.5  (25.66)  
Gender  
[units: participants]
 
Female     27  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures
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1.  Primary:   Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit   [ Time Frame: 6 to 8 days after treatment ]

2.  Secondary:   Clinical Response at Follow up as Assessed by a Rating Scale   [ Time Frame: 6 to 8 days after treatment ]

3.  Secondary:   Microbiologic Response at Follow up as Assessed by a Rating Scale   [ Time Frame: 6 to 8 days after treatment ]

4.  Secondary:   Number of Participants Who Were a Therapeutic Success   [ Time Frame: 6 to 8 days after treatment ]

5.  Secondary:   Erythema (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

6.  Secondary:   Erythema (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

7.  Secondary:   Purulence (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

8.  Secondary:   Purulence (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

9.  Secondary:   Crusting (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

10.  Secondary:   Crusting (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

11.  Secondary:   Tissue Edema (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

12.  Secondary:   Tissue Edema (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

13.  Secondary:   Tissue Warmth (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

14.  Secondary:   Tissue Warmth (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

15.  Secondary:   Pain (Sign and Symptom of Infection) at Baseline   [ Time Frame: baseline ]

16.  Secondary:   Pain (Sign and Symptom of Infection) at Follow up   [ Time Frame: 6 to 8 days after treatment ]

17.  Secondary:   Wound Size at Baseline   [ Time Frame: baseline ]

18.  Secondary:   Wound Size at Follow up   [ Time Frame: 6 to 8 days after treatment ]

19.  Secondary:   Number of Participants Reporting Any Adverse Event (AE)   [ Time Frame: baseline to 6 to 8 days after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Adelaide A Hebert
Organization: The University of Texas Health Science Center at Houston
phone: (713) 500-8339
e-mail: Adelaide.A.Hebert@uth.tmc.edu


Publications of Results:
Bohaty BR, Choi S, Cai C, Hebert AA. Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. International Journal of Women's Dermatology 1: 13-20, 2015.


Responsible Party: Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01126268     History of Changes
Other Study ID Numbers: HSC-MS-09-0650
Study First Received: April 19, 2010
Results First Received: December 14, 2015
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration