Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01355471
First received: May 16, 2011
Last updated: September 19, 2013
Last verified: September 2013
Results First Received: September 19, 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
Condition: Rosacea
Interventions: Drug: CD07805/47 Gel
Drug: Placebo

  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
CD07805/47 Gel No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    CD07805/47 Gel     Placebo  
STARTED     148     145  
COMPLETED     141     142  
NOT COMPLETED     7     3  



  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
CD07805/47 Gel No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    CD07805/47 Gel     Placebo     Total  
Number of Participants  
[units: participants]
  148     145     293  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     136     134     270  
>=65 years     12     11     23  
Age  
[units: years]
Mean ± Standard Deviation
  48.5  ± 11.94     46.5  ± 12.10     47.5  ± 12.04  
Gender  
[units: participants]
     
Female     105     108     213  
Male     43     37     80  
Region of Enrollment  
[units: participants]
     
United States     140     138     278  
Canada     8     7     15  



  Outcome Measures

1.  Primary:   Composite Success   [ Time Frame: Day 29 ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Michael Graeber, MD
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01355471     History of Changes
Other Study ID Numbers: RD.06.SPR.18141
Study First Received: May 16, 2011
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration