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Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

This study has been completed.
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00855595
First received: March 3, 2009
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Papulopustular Rosacea
Interventions: Drug: Azelaic acid (Finacea, BAY39-6251)
Drug: Metronidazole (Metrogel)
Drug: Doxycycline (Oracea)

  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
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Metronidazole (Metrogel) Plus Doxycycline (Oracea) Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks

Participant Flow:   Overall Study
    Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)     Metronidazole (Metrogel) Plus Doxycycline (Oracea)  
STARTED     106     101  
COMPLETED     100     94  
NOT COMPLETED     6     7  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 3                 3  
Adverse Event                 1                 1  
patient moved out of state                 1                 0  
patient left country                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Metronidazole (Metrogel) Plus Doxycycline (Oracea) Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)     Metronidazole (Metrogel) Plus Doxycycline (Oracea)     Total  
Number of Participants  
[units: participants]
 		  106     101     207  
Age  
[units: Years]
Mean ± Standard Deviation 		  50.4  ± 12.7     48.4  ± 11.5     49.4  ± 12.2  
Gender  
[units: Participants]
 		     
Female     67     69     136  
Male     39     32     71  
Investigator’s Global Assessment (IGA) score at Baseline [1]
[units: Participants]
 		     
IGA Score 4 - Moderate     79     76     155  
IGA Score 5 - Moderate to Severe     26     22     48  
IGA Score 6- Severe     1     3     4  
Number of lesions at Baseline  
[units: Lesions]
Mean ± Standard Deviation 		  20.6  ± 11.01     21.9  ± 10.50     21.3  ± 10.76  
Previous duration of rosacea  
[units: Months]
Mean ± Standard Deviation 		  130.8  ± 126.1     134.9  ± 107.2     132.8  ± 117.0  
[1] IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).



  Outcome Measures
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1.  Primary:   Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)   [ Time Frame: Baseline and Week 2 ]
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2.  Secondary:   Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)   [ Time Frame: Week 2, 4, 6, 8 and 12 ]
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3.  Secondary:   Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)   [ Time Frame: Baseline and Week 4, 6, 8 and 12 ]
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4.  Secondary:   Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)   [ Time Frame: Baseline and Week 2, 4, 6, 8 and 12 ]
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5.  Secondary:   Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)   [ Time Frame: Baseline and Weeks 2, 4, 6, 8 and 12 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)   [ Time Frame: Weeks 2, 4, 6, 8 and 12 ]
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7.  Secondary:   Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)   [ Time Frame: Weeks 2, 4, 6, 8 and 12 ]
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8.  Secondary:   Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2   [ Time Frame: At Week 2 ]
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9.  Secondary:   Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4   [ Time Frame: At Week 4 ]
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10.  Secondary:   Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6   [ Time Frame: At Week 6 ]
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11.  Secondary:   Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8   [ Time Frame: At Week 8 ]
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12.  Secondary:   Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12   [ Time Frame: At Week 12 ]
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13.  Secondary:   Investigator Rating of Overall Improvement at End of Study (Week 12)   [ Time Frame: Week 12 ]
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14.  Secondary:   Patient Rating of Overall Improvement at End of Study (Week 12)   [ Time Frame: Week 12 ]
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15.  Secondary:   Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)   [ Time Frame: Week 12 ]
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16.  Other Pre-specified:   Patient Opinion of Local Tolerability   [ Time Frame: Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Intendis GmbH
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Global Clinical Development, Bayer Healthcare LLC (formerly Intendis Inc.)
ClinicalTrials.gov Identifier: NCT00855595     History of Changes
Other Study ID Numbers: 1402604, 1402604, 256-0024
Study First Received: March 3, 2009
Results First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: United States: Institutional Review Board