Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01579084
First received: April 13, 2012
Last updated: September 12, 2013
Last verified: September 2013
Results First Received: September 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Rosacea
Erythema
Interventions: Drug: AGN-199201 Formulation A
Drug: AGN-199201 Formulation B
Drug: AGN-199201 Formulation C
Drug: AGN-199201 Vehicle

  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
No text entered.

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
AGN-199201 Formulation A and B AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation B and C AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation C and A AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation A and Vehicle AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation B and Vehicle AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation C and Vehicle AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation A AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
AGN-199201 Formulation B AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
AGN-199201 Formulation C AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
AGN-199201 Vehicle AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.

Participant Flow:   Overall Study
    AGN-199201 Formulation A and B     AGN-199201 Formulation B and C     AGN-199201 Formulation C and A     AGN-199201 Formulation A and Vehicle     AGN-199201 Formulation B and Vehicle     AGN-199201 Formulation C and Vehicle     AGN-199201 Formulation A     AGN-199201 Formulation B     AGN-199201 Formulation C     AGN-199201 Vehicle  
STARTED     8     8     8     8     8     8     4     4     4     4  
COMPLETED     8     8     8     8     8     8     4     4     4     4  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
AGN-199201 Formulation A and B AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation B and C AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation C and A AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation A and Vehicle AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation B and Vehicle AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation C and Vehicle AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
AGN-199201 Formulation A AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
AGN-199201 Formulation B AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
AGN-199201 Formulation C AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
AGN-199201 Vehicle AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
Total Total of all reporting groups

Baseline Measures
    AGN-199201 Formulation A and B     AGN-199201 Formulation B and C     AGN-199201 Formulation C and A     AGN-199201 Formulation A and Vehicle     AGN-199201 Formulation B and Vehicle     AGN-199201 Formulation C and Vehicle     AGN-199201 Formulation A     AGN-199201 Formulation B     AGN-199201 Formulation C     AGN-199201 Vehicle     Total  
Number of Participants  
[units: participants]
  8     8     8     8     8     8     4     4     4     4     64  
Age, Customized  
[units: Participants]
                     
< 45 years     1     1     1     4     0     1     0     1     1     0     10  
45 to 65 years     7     6     6     4     8     7     3     3     2     4     50  
> 65 years     0     1     1     0     0     0     1     0     1     0     4  
Gender  
[units: Participants]
                     
Female     5     8     6     7     5     7     2     4     2     3     49  
Male     3     0     2     1     3     1     2     0     2     1     15  



  Outcome Measures
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1.  Primary:   Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 1   [ Time Frame: Baseline, Day 1-hour 6 ]

2.  Primary:   Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 5   [ Time Frame: Baseline, Day 5-hour 6 ]

3.  Secondary:   Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA   [ Time Frame: Baseline, Day 1-hour 6, Day 5-hour 6 ]

4.  Secondary:   Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA   [ Time Frame: Baseline, Day1-hour 6, Day 5-hour 6 ]


  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: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01579084     History of Changes
Other Study ID Numbers: 199201-001
Study First Received: April 13, 2012
Results First Received: September 12, 2013
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration