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Combination Gel and Vascular ND in Mild to Moderate Rosacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631656
First Posted: June 29, 2012
Last Update Posted: November 28, 2017
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.
Collaborator:
Bayer
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rosacea
Interventions: Drug: Azelaic acid
Device: Nd:Yag laser

  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 Left Side Plus Laser

Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.

Azelaic acid: 15% gel, twice daily, 6 weeks

Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.

Azelaic Acid Right Side Plus Laser

Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.

Azelaic acid: 15% gel, twice daily, 6 weeks

Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.


Participant Flow:   Overall Study
    Azelaic Acid Left Side Plus Laser   Azelaic Acid Right Side Plus Laser
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   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
Azelaic Acid Left Side Plus Laser

Azelaic acid 15% twice daily for 6 weeks to the left side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.

Azelaic acid: 15% gel, twice daily, 6 weeks

Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.

Azelaic Acid Right Side Plus Laser

Azelaic acid 15% twice daily for 6 weeks to the right side of the face, plus laser treatment with Nd:Yag laser once at 2 weeks.

Azelaic acid: 15% gel, twice daily, 6 weeks

Nd:Yag laser: Treatment with Nd:Yag laser to all the face, once at Week 2.

Total Total of all reporting groups

Baseline Measures
   Azelaic Acid Left Side Plus Laser   Azelaic Acid Right Side Plus Laser   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      5 100.0%      10 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  80.0%      5 100.0%      9  90.0% 
Male      1  20.0%      0   0.0%      1  10.0% 


  Outcome Measures

1.  Primary:   IGA of Improvement   [ Time Frame: 6 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Amy McMichael
Organization: WakeForest University Health Sciences
phone: 336-716-3775
e-mail: amcmicha@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01631656     History of Changes
Other Study ID Numbers: II-AM-Intendis-ROS
First Submitted: June 27, 2012
First Posted: June 29, 2012
Results First Submitted: October 20, 2016
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017