Trial Outcomes & Findings for Azelaic Acid on Demodex Counts in Rosacea (NCT NCT03035955)
NCT ID: NCT03035955
Last Updated: 2018-09-07
Results Overview
number of demodex at Baseline and Week 4. Only Week 4 reported
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Week 4
Results posted on
2018-09-07
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azelaic Acid on Demodex Counts in Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid Left/No Treatment Right
n=10 Participants
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
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4number of demodex at Baseline and Week 4. Only Week 4 reported
Outcome measures
| Measure |
Azelaic Acid Left/no Treatment Right
n=10 Participants
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
n=10 Participants
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
|
|---|---|---|
|
Demodex Count
|
40 number of demodex
|
18 number of demodex
|
Adverse Events
Azelaic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
WakeForest
Phone: 336-716-3775
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place