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Azelaic Acid on Demodex Counts in Rosacea

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ClinicalTrials.gov Identifier: NCT03035955
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Rosacea
Intervention: Drug: Azelaic acid

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Azelaic Acid Left/No Treatment Right

azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face

Azelaic acid: 15% gel twice daily for four weeks to the left side of face

Azelaic Acid Right/No Treatment Left

azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face

Azelaic acid: 15% gel twice daily for four weeks to the right side of face


Participant Flow:   Overall Study
    Azelaic Acid Left/No Treatment Right   Azelaic Acid Right/No Treatment Left
STARTED   10   10 
COMPLETED   9   9 
NOT COMPLETED   1   1 



  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.
No text entered.

Reporting Groups
  Description
Azelaic Acid Left/No Treatment Right azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
Azelaic Acid Right/No Treatment Left azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
Total Total of all reporting groups

Baseline Measures
   Azelaic Acid Left/No Treatment Right   Azelaic Acid Right/No Treatment Left   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      10 100.0%      20 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  80.0%      9  90.0%      17  85.0% 
Male      2  20.0%      1  10.0%      3  15.0% 


  Outcome Measures

1.  Primary:   Demodex Count   [ Time Frame: Week 4 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: WakeForest
phone: 336-716-3775



Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT03035955     History of Changes
Other Study ID Numbers: Intendis - Demodex Rosacea
First Submitted: December 19, 2012
First Posted: January 30, 2017
Results First Submitted: February 28, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017