Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01555463
First received: March 13, 2012
Last updated: December 28, 2015
Last verified: December 2015
Results First Received: December 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Papulopustular Rosacea
Interventions: Drug: Azelaic acid foam, 15% (BAY39-6251)
Drug: Vehicle foam

  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 Foam, 15% (BAY39-6251) 0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
Vehicle Foam 0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.

Participant Flow for 2 periods

Period 1:   Treatment
    Azelaic Acid Foam, 15% (BAY39-6251)     Vehicle Foam  
STARTED     483     478  
COMPLETED     419     399  
NOT COMPLETED     64     79  
Adverse Event                 6                 12  
Withdrawal by Subject                 24                 36  
Lost to Follow-up                 28                 23  
Protocol Violation                 4                 5  
Other reason                 2                 3  

Period 2:   Follow up
    Azelaic Acid Foam, 15% (BAY39-6251)     Vehicle Foam  
STARTED     447 [1]   439 [1]
COMPLETED     409     394  
NOT COMPLETED     38     45  
Adverse Event                 2                 5  
Death                 0                 1  
Withdrawal by Subject                 22                 22  
Lost to Follow-up                 9                 10  
Protocol Violation                 2                 4  
Other reason                 3                 3  
[1] Treatment completers and non-completers were asked to participate in the follow-up phase.



  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
Azelaic Acid Foam, 15% (BAY39-6251) 0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
Vehicle Foam 0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Azelaic Acid Foam, 15% (BAY39-6251)     Vehicle Foam     Total  
Number of Participants  
[units: participants]
  483     478     961  
Age  
[units: Years]
Mean (Standard Deviation)
  51.2  (12.3)     51.9  (13.2)     51.5  (12.8)  
Gender  
[units: Participants]
     
Female     354     348     702  
Male     129     130     259  
Investigator’s Global Assessment (IGA) [1]
[units: Participants]
     
Clear     0     0     0  
Minimal     0     0     0  
Mild     0     0     0  
Moderate     418     416     834  
Severe     65     62     127  
Lesion count  
[units: Inflammatory lesions]
Mean (Standard Deviation)
  21.7  (9.1)     21.2  (8.7)     21.4  (8.9)  
Erythema rating  
[units: Participants]
     
Clear or almost clear     0     0     0  
Mild     43     39     82  
Moderate     364     370     734  
Severe     76     69     145  
[1] The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

2.  Primary:   Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)   [ Time Frame: Baseline and end of treatment (LOCF), up to 12 weeks ]

3.  Secondary:   Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)   [ Time Frame: Baseline and end of treatment (LOCF), up to 12 weeks ]

4.  Secondary:   Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

5.  Secondary:   Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)   [ Time Frame: Baseline and end of treatment (LOCF), up to 12 weeks ]

6.  Secondary:   Percentage of Participants With Investigator’s Global Assessment (IGA) Scores at End of Treatment (LOCF)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

7.  Secondary:   Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

8.  Secondary:   Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

9.  Secondary:   Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)   [ Time Frame: Baseline and end of treatment (LOCF), up to 12 weeks ]

10.  Secondary:   Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)   [ Time Frame: At end of treatment (LOCF), up to 12 weeks ]

11.  Secondary:   Participants' Global Assessment of Treatment Response at End of Treatment   [ Time Frame: At end of treatment, up to 12 weeks ]

12.  Secondary:   Participants' Global Assessment of Tolerability at End of Treatment   [ Time Frame: At end of treatment, up to 12 weeks ]

13.  Secondary:   Participants' Opinion on Cosmetic Acceptability at End of Treatment   [ Time Frame: At end of treatment, up to 12 weeks ]

14.  Secondary:   Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment   [ Time Frame: At end of treatment, up to 12 weeks ]

15.  Secondary:   Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score   [ Time Frame: Baseline and end of treatment, up to 12 weeks ]

16.  Secondary:   Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score   [ Time Frame: Baseline and end of treatment, up to 12 weeks ]

17.  Secondary:   Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment   [ Time Frame: Baseline and end of treatment, up to 12 weeks ]

18.  Secondary:   Change From Baseline in Index Value at End of Treatment   [ Time Frame: Baseline and end of treatment, up to 12 weeks ]


  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 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.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01555463     History of Changes
Other Study ID Numbers: 16080
1401846 ( Other Identifier: Company Internal )
Study First Received: March 13, 2012
Results First Received: December 28, 2014
Last Updated: December 28, 2015
Health Authority: United States: Food and Drug Administration