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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 : September 7, 2018
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
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azelaic Acid Left/No Treatment Right Azelaic Acid Right/No Treatment Left
Hide Arm/Group Description

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 (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

Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Arm/Group Title Azelaic Acid Left/No Treatment Right Azelaic Acid Right/No Treatment Left Total
Hide Arm/Group Description 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 (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
9
  90.0%
17
  85.0%
Male
2
  20.0%
1
  10.0%
3
  15.0%
1.Primary Outcome
Title Demodex Count
Hide Description number of demodex at Baseline and Week 4. Only Week 4 reported
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azelaic Acid Left/no Treatment Right Azelaic Acid Right /no Treatment Left
Hide Arm/Group Description:
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 (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: number of demodex
40 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azelaic Acid no Treatment
Hide Arm/Group Description

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

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

no treatment on the other side of the face
All-Cause Mortality
Azelaic Acid no Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Azelaic Acid no Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azelaic Acid no Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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: IRB00014511
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: September 7, 2018