Trial Outcomes & Findings for Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea (NCT NCT00617903)
NCT ID: NCT00617903
Last Updated: 2020-04-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Baseline and End of Study (Week 12)
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
noncompliance
|
0
|
1
|
Baseline Characteristics
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
51.5 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
50.5 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Previous duration of rosacea
|
88.5 Months
STANDARD_DEVIATION 63.8 • n=5 Participants
|
91.9 Months
STANDARD_DEVIATION 77.0 • n=7 Participants
|
90.2 Months
STANDARD_DEVIATION 70.4 • n=5 Participants
|
|
Investigator's Global Assessment (IGA) score at Baseline
|
4.0 Scores on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.9 Scores on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants
|
3.9 Scores on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Number of inflammatory lesions per participant at Baseline
|
18.0 Inflammatory lesions
STANDARD_DEVIATION 10.61 • n=5 Participants
|
17.6 Inflammatory lesions
STANDARD_DEVIATION 8.36 • n=7 Participants
|
17.8 Inflammatory lesions
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Erythema intensity score at baseline
|
3.1 Scores on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.0 Scores on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.0 Scores on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Study (Week 12)Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)
|
-11.7 Inflammatory lesions
Standard Deviation 8.53
|
-10.8 Inflammatory lesions
Standard Deviation 7.80
|
PRIMARY outcome
Timeframe: At End of Study (Week 12)IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
|
46.3 Percentage of participants
|
47.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and End of Study (Week 12)Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Improved
|
61.0 Percentage of participants
|
47.6 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
No change
|
36.6 Percentage of participants
|
45.2 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Worse
|
2.4 Percentage of participants
|
7.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
9.1 Inflammatory lesions
Standard Deviation 7.93
|
11.7 Inflammatory lesions
Standard Deviation 9.23
|
|
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
6.8 Inflammatory lesions
Standard Deviation 7.59
|
6.6 Inflammatory lesions
Standard Deviation 5.57
|
|
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
4.3 Inflammatory lesions
Standard Deviation 5.86
|
4.6 Inflammatory lesions
Standard Deviation 5.47
|
|
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
6.3 Inflammatory lesions
Standard Deviation 10.64
|
6.8 Inflammatory lesions
Standard Deviation 8.46
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Week 8
|
-9.9 Inflammatory lesions
Standard Deviation 5.88
|
-10.3 Inflammatory lesions
Standard Deviation 6.62
|
|
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Week 4
|
-7.5 Inflammatory lesions
Standard Deviation 4.68
|
-5.8 Inflammatory lesions
Standard Deviation 4.95
|
|
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Week 12
|
-12.4 Inflammatory lesions
Standard Deviation 8.38
|
-12.4 Inflammatory lesions
Standard Deviation 7.26
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
-49.5 Percent change in Inflammatory lesions
Standard Deviation 23.68
|
-37.7 Percent change in Inflammatory lesions
Standard Deviation 36.70
|
|
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
-62.7 Percent change in Inflammatory lesions
Standard Deviation 29.82
|
-62.8 Percent change in Inflammatory lesions
Standard Deviation 27.71
|
|
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
-75.1 Percent change in Inflammatory lesions
Standard Deviation 33.80
|
-74.8 Percent change in Inflammatory lesions
Standard Deviation 32.40
|
|
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
-71.2 Percent change in Inflammatory lesions
Standard Deviation 36.42
|
-65.3 Percent change in Inflammatory lesions
Standard Deviation 40.11
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-clear
|
0 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-minimal
|
20.5 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-mild
|
17.9 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-mild to moderate
|
23.1 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-moderate
|
30.8 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-moderate to severe
|
7.7 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-severe
|
0 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-clear
|
7.9 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-minimal
|
28.9 Percentage of participants
|
27.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-mild
|
18.4 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-mild to moderate
|
21.1 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-moderate
|
15.8 Percentage of participants
|
21.6 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-moderate to severe
|
7.9 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-severe
|
0 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-clear
|
10.5 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-minimal
|
36.8 Percentage of participants
|
37.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-mild
|
26.3 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-mild to moderate
|
21.1 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-moderate
|
0 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-moderate to severe
|
5.3 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-severe
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-clear
|
9.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-minimal
|
36.6 Percentage of participants
|
31.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-mild
|
24.4 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-mild to moderate
|
19.5 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-moderate
|
0 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-moderate to severe
|
7.3 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-severe
|
2.4 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
-1.0 Scores on a scale
Standard Deviation 1.2
|
-0.7 Scores on a scale
Standard Deviation 1.1
|
|
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
-1.6 Scores on a scale
Standard Deviation 1.3
|
-1.3 Scores on a scale
Standard Deviation 1.4
|
|
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
-2.1 Scores on a scale
Standard Deviation 1.2
|
-1.9 Scores on a scale
Standard Deviation 1.3
|
|
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
-2.0 Scores on a scale
Standard Deviation 1.3
|
-1.7 Scores on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-clear or almost clear
|
5.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-mild
|
30.8 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-moderate
|
51.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-severe
|
12.8 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-clear or almost clear
|
13.2 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-mild
|
36.8 Percentage of participants
|
32.4 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-moderate
|
42.1 Percentage of participants
|
45.9 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-severe
|
7.9 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-clear or almost clear
|
18.4 Percentage of participants
|
25.7 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-mild
|
42.1 Percentage of participants
|
22.9 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-moderate
|
34.2 Percentage of participants
|
45.7 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-severe
|
5.3 Percentage of participants
|
5.7 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-clear or almost clear
|
17.1 Percentage of participants
|
21.4 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-mild
|
41.5 Percentage of participants
|
21.4 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-moderate
|
34.1 Percentage of participants
|
52.4 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-severe
|
7.3 Percentage of participants
|
4.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
-0.3 Scores on a scale
Standard Deviation 0.6
|
-0.4 Scores on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
-0.6 Scores on a scale
Standard Deviation 0.7
|
-0.5 Scores on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
-0.8 Scores on a scale
Standard Deviation 0.8
|
-0.7 Scores on a scale
Standard Deviation 1.0
|
|
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
-0.8 Scores on a scale
Standard Deviation 0.8
|
-0.6 Scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 4-Improved
|
35.9 Percentage of participants
|
42.1 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 4-No change
|
59.0 Percentage of participants
|
52.6 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 4-Worse
|
5.1 Percentage of participants
|
5.3 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 8-Improved
|
50.0 Percentage of participants
|
48.6 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 8-No change
|
50.0 Percentage of participants
|
40.5 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 8-Worse
|
0 Percentage of participants
|
10.8 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 12-Improved
|
63.2 Percentage of participants
|
54.3 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 12-No change
|
34.2 Percentage of participants
|
37.1 Percentage of participants
|
|
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Week 12-Worse
|
2.6 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-none
|
0 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-mild
|
35.9 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-moderate
|
64.1 Percentage of participants
|
55.3 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-severe
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-none
|
0 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-mild
|
42.1 Percentage of participants
|
56.8 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-moderate
|
57.9 Percentage of participants
|
37.8 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-severe
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-none
|
2.6 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-mild
|
42.1 Percentage of participants
|
62.9 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-moderate
|
55.3 Percentage of participants
|
34.3 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-severe
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-none
|
2.4 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-mild
|
41.5 Percentage of participants
|
59.5 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-moderate
|
56.1 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-severe
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
0.0 Scores on a scale
Standard Deviation 0.3
|
-0.1 Scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
-0.1 Scores on a scale
Standard Deviation 0.3
|
-0.3 Scores on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
-0.2 Scores on a scale
Standard Deviation 0.4
|
-0.3 Scores on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
-0.1 Scores on a scale
Standard Deviation 0.4
|
-0.2 Scores on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-Improved
|
5.1 Percentage of participants
|
10.5 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-No change
|
92.3 Percentage of participants
|
86.8 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4-Worse
|
2.6 Percentage of participants
|
2.6 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-Improved
|
10.5 Percentage of participants
|
27.0 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-No change
|
89.5 Percentage of participants
|
73.0 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8-Worse
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-Improved
|
15.8 Percentage of participants
|
28.6 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-No change
|
84.2 Percentage of participants
|
71.4 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12-Worse
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-Improved
|
14.6 Percentage of participants
|
23.8 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-No change
|
85.4 Percentage of participants
|
76.2 Percentage of participants
|
|
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study-Worse
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At End of Study (Week 12)Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)
Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=38 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=40 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Investigator's Rating of Overall Improvement at End of Study
Excellent Improvement
|
34.2 Percentage of participants
|
40.0 Percentage of participants
|
|
Investigator's Rating of Overall Improvement at End of Study
Marked Improvement
|
23.7 Percentage of participants
|
17.5 Percentage of participants
|
|
Investigator's Rating of Overall Improvement at End of Study
Moderate Improvement
|
31.6 Percentage of participants
|
27.5 Percentage of participants
|
|
Investigator's Rating of Overall Improvement at End of Study
No Improvement
|
7.9 Percentage of participants
|
12.5 Percentage of participants
|
|
Investigator's Rating of Overall Improvement at End of Study
Deterioration
|
2.6 Percentage of participants
|
2.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At End of Study (Week 12)Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases
Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=38 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=40 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Patients' Rating of Overall Improvement at End of Study
Excellent Improvement
|
36.8 Percentage of participants
|
27.5 Percentage of participants
|
|
Patients' Rating of Overall Improvement at End of Study
Good Improvement
|
28.9 Percentage of participants
|
22.5 Percentage of participants
|
|
Patients' Rating of Overall Improvement at End of Study
Fair Improvement
|
21.1 Percentage of participants
|
22.5 Percentage of participants
|
|
Patients' Rating of Overall Improvement at End of Study
No Improvement
|
5.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Patients' Rating of Overall Improvement at End of Study
Worse
|
7.9 Percentage of participants
|
7.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At End of Study (Week 12)Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases
Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=38 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=40 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Patients' Opinion on Cosmetic Acceptability at End of Study
Very Good
|
42.1 Percentage of participants
|
35.0 Percentage of participants
|
|
Patients' Opinion on Cosmetic Acceptability at End of Study
Good
|
36.8 Percentage of participants
|
37.5 Percentage of participants
|
|
Patients' Opinion on Cosmetic Acceptability at End of Study
Satisfactory
|
10.5 Percentage of participants
|
5.0 Percentage of participants
|
|
Patients' Opinion on Cosmetic Acceptability at End of Study
Poor
|
5.3 Percentage of participants
|
10.0 Percentage of participants
|
|
Patients' Opinion on Cosmetic Acceptability at End of Study
No Opinion
|
5.3 Percentage of participants
|
12.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8 and 12IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Week 8
|
36.8 Percentage of participants
|
35.1 Percentage of participants
|
|
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Week 4
|
20.5 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Week 12
|
47.4 Percentage of participants
|
54.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Week 4
|
38.5 Percentage of participants
|
34.2 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Week 8
|
55.3 Percentage of participants
|
51.4 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Week 12
|
73.7 Percentage of participants
|
62.9 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
End of Study
|
70.7 Percentage of participants
|
54.8 Percentage of participants
|
Adverse Events
Azelaic Acid Foam, 15% (BAY39-6251)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=41 participants at risk
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=42 participants at risk
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Administration site reaction
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
|
General disorders
Application site irritation
|
9.8%
4/41 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infection
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Number of events 2
|
0.00%
0/42
|
|
Infections and infestations
Vaginitis bacterial
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
Headache
|
0.00%
0/41
|
4.8%
2/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.4%
1/41 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/41
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
2/41 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.4%
1/41 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A) Investigator shall provide Sponsor with intended publication 60 days upfront publication date, Sponsor has 30 d to comment, recommended changes shall not be unreasonably refused B) Sponsor has the right to ask Investigator to delay publication for a maximum of 90 days C) Investigative data will be pooled and published by Sponsor - no other publication without the consent of all parties prior to publication of the pooled data, or within 12 months after LPLV, whatever comes first
- Publication restrictions are in place
Restriction type: OTHER