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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355471
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Rosacea
Interventions: Drug: CD07805/47 Gel
Drug: Placebo

  Participant Flow

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

Participant Flow:   Overall Study
    CD07805/47 Gel   Placebo
STARTED   148   145 
COMPLETED   141   142 

  Baseline Characteristics

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

Baseline Measures
   CD07805/47 Gel   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   145   293 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   136   134   270 
>=65 years   12   11   23 
[Units: Years]
Mean (Standard Deviation)
 48.5  (11.94)   46.5  (12.10)   47.5  (12.04) 
[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

  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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  More Information

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.

Results Point of Contact:  
Name/Title: Michael Graeber, MD
Organization: Galderma
phone: 609-860-8201

Responsible Party: Galderma Identifier: NCT01355471     History of Changes
Other Study ID Numbers: RD.06.SPR.18141
First Submitted: May 16, 2011
First Posted: May 18, 2011
Results First Submitted: September 19, 2013
Results First Posted: November 21, 2013
Last Update Posted: November 21, 2013