Trial Outcomes & Findings for Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea (NCT NCT00855595)
NCT ID: NCT00855595
Last Updated: 2020-03-31
Results Overview
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
207 participants
Primary outcome timeframe
Baseline and Week 2
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
101
|
|
Overall Study
COMPLETED
|
100
|
94
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
patient moved out of state
|
1
|
0
|
|
Overall Study
patient left country
|
0
|
1
|
Baseline Characteristics
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
49.4 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA) score at Baseline
IGA Score 4 - Moderate
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA) score at Baseline
IGA Score 5 - Moderate to Severe
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA) score at Baseline
IGA Score 6- Severe
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of lesions at Baseline
|
20.6 Lesions
STANDARD_DEVIATION 11.01 • n=5 Participants
|
21.9 Lesions
STANDARD_DEVIATION 10.50 • n=7 Participants
|
21.3 Lesions
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Previous duration of rosacea
|
130.8 Months
STANDARD_DEVIATION 126.1 • n=5 Participants
|
134.9 Months
STANDARD_DEVIATION 107.2 • n=7 Participants
|
132.8 Months
STANDARD_DEVIATION 117.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: Full analysis set (FAS)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
|
-10.5 Inflammatory lesions
Standard Deviation 9.14
|
-9.4 Inflammatory lesions
Standard Deviation 9.38
|
SECONDARY outcome
Timeframe: Week 2, 4, 6, 8 and 12Population: FAS
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2
|
10.1 Inflammatory lesions
Standard Deviation 8.70
|
12.5 Inflammatory lesions
Standard Deviation 9.86
|
|
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4
|
7.4 Inflammatory lesions
Standard Deviation 7.29
|
9.5 Inflammatory lesions
Standard Deviation 8.09
|
|
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6
|
5.9 Inflammatory lesions
Standard Deviation 6.28
|
7.8 Inflammatory lesions
Standard Deviation 7.18
|
|
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8
|
5.1 Inflammatory lesions
Standard Deviation 6.28
|
6.4 Inflammatory lesions
Standard Deviation 7.02
|
|
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12
|
4.4 Inflammatory lesions
Standard Deviation 6.51
|
5.7 Inflammatory lesions
Standard Deviation 7.22
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 6, 8 and 12Population: FAS
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Week 4
|
-13.2 Inflammatory lesions
Standard Deviation 9.03
|
-12.4 Inflammatory lesions
Standard Deviation 9.23
|
|
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Week 6
|
-14.8 Inflammatory lesions
Standard Deviation 9.20
|
-14.1 Inflammatory lesions
Standard Deviation 9.32
|
|
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Week 8
|
-15.5 Inflammatory lesions
Standard Deviation 9.69
|
-15.6 Inflammatory lesions
Standard Deviation 9.82
|
|
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Week 12
|
-16.2 Inflammatory lesions
Standard Deviation 9.88
|
-16.2 Inflammatory lesions
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 6, 8 and 12Population: FAS
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2
|
-50.7 Percent of inflammatory lesions
Standard Deviation 29.39
|
-43.0 Percent of inflammatory lesions
Standard Deviation 35.68
|
|
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4
|
-64.9 Percent of inflammatory lesions
Standard Deviation 28.93
|
-56.9 Percent of inflammatory lesions
Standard Deviation 31.50
|
|
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6
|
-72.4 Percent of inflammatory lesions
Standard Deviation 24.67
|
-64.5 Percent of inflammatory lesions
Standard Deviation 29.00
|
|
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8
|
-76.4 Percent of inflammatory lesions
Standard Deviation 23.47
|
-71.6 Percent of inflammatory lesions
Standard Deviation 26.94
|
|
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12
|
-80.2 Percent of inflammatory lesions
Standard Deviation 24.25
|
-75.1 Percent of inflammatory lesions
Standard Deviation 27.25
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8 and 12Population: FAS
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2, ≥25% improvement
|
84.9 Percentage of participants
|
77.2 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2, ≥50% improvement
|
61.3 Percentage of participants
|
47.5 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2, ≥75% improvement
|
20.8 Percentage of participants
|
17.8 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4, ≥25% improvement
|
90.6 Percentage of participants
|
81.2 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4, ≥50% improvement
|
75.5 Percentage of participants
|
64.4 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4, ≥75% improvement
|
44.3 Percentage of participants
|
40.6 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6, ≥25% improvement
|
95.3 Percentage of participants
|
91.1 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6, ≥50% improvement
|
84.9 Percentage of participants
|
78.2 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6, ≥75% improvement
|
54.7 Percentage of participants
|
43.6 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8, ≥25% improvement
|
95.3 Percentage of participants
|
90.1 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8, ≥50% improvement
|
88.7 Percentage of participants
|
87.1 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8, ≥75% improvement
|
67.0 Percentage of participants
|
55.4 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12, ≥25% improvement
|
96.2 Percentage of participants
|
91.1 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12, ≥50% improvement
|
89.6 Percentage of participants
|
85.1 Percentage of participants
|
|
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12, ≥75% improvement
|
68.9 Percentage of participants
|
65.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8 and 12Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2
|
13.2 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4
|
32.1 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6
|
45.3 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8
|
50.9 Percentage of participants
|
39.6 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12
|
62.3 Percentage of participants
|
52.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8 and 12Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2
|
32.1 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 4
|
55.7 Percentage of participants
|
44.6 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 6
|
60.4 Percentage of participants
|
53.5 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 8
|
72.6 Percentage of participants
|
59.4 Percentage of participants
|
|
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 12
|
78.3 Percentage of participants
|
72.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 2Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
6 - Severe
|
0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
0 - Clear
|
0.9 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
1 - Minimal
|
12.3 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
3 - Mild to moderate
|
33.0 Percentage of participants
|
31.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
4 - Moderate
|
25.5 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
5 - Moderate to severe
|
9.4 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
2 - Mild
|
18.9 Percentage of participants
|
19.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 4Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
0 - Clear
|
7.5 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
1 - Minimal
|
24.5 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
2 - Mild
|
23.6 Percentage of participants
|
17.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
3 - Mild to moderate
|
24.5 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
4 - Moderate
|
15.1 Percentage of participants
|
20.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
5 - Moderate to severe
|
4.7 Percentage of participants
|
9.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
6 - Severe
|
0 Percentage of participants
|
1.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 6Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
0 - Clear
|
18.9 Percentage of participants
|
9.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
1 - Minimal
|
26.4 Percentage of participants
|
17.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
2 - Mild
|
15.1 Percentage of participants
|
25.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
3 - Mild to moderate
|
24.5 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
4 - Moderate
|
11.3 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
5 - Moderate to severe
|
3.8 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
6 - Severe
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
0 - Clear
|
18.9 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
1 - Minimal
|
32.1 Percentage of participants
|
25.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
2 - Mild
|
21.7 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
3 - Mild to moderate
|
14.2 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
4 - Moderate
|
10.4 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
5 - Moderate to severe
|
2.8 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
6 - Severe
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: FAS
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
0 - Clear
|
30.2 Percentage of participants
|
22.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
1 - Minimal
|
32.1 Percentage of participants
|
29.7 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
2 - Mild
|
16.0 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
3 - Mild to moderate
|
12.3 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
4 - Moderate
|
6.6 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
5 - Moderate to severe
|
1.9 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
6 - Severe
|
0.9 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the FAS who took part in this evaluation.
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=103 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=97 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Investigator Rating of Overall Improvement at End of Study (Week 12)
Excellent Improvement
|
46.6 Percentage of participants
|
42.3 Percentage of participants
|
|
Investigator Rating of Overall Improvement at End of Study (Week 12)
Marked Improvement
|
35.9 Percentage of participants
|
34.0 Percentage of participants
|
|
Investigator Rating of Overall Improvement at End of Study (Week 12)
Moderate Improvement
|
12.6 Percentage of participants
|
17.5 Percentage of participants
|
|
Investigator Rating of Overall Improvement at End of Study (Week 12)
No change
|
4.9 Percentage of participants
|
6.2 Percentage of participants
|
|
Investigator Rating of Overall Improvement at End of Study (Week 12)
Deterioration
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the FAS who took part in this evaluation.
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=102 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=96 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Patient Rating of Overall Improvement at End of Study (Week 12)
Excellent Improvement
|
51.0 Percentage of participants
|
49.0 Percentage of participants
|
|
Patient Rating of Overall Improvement at End of Study (Week 12)
Good Improvement
|
39.2 Percentage of participants
|
33.3 Percentage of participants
|
|
Patient Rating of Overall Improvement at End of Study (Week 12)
Fair Improvement
|
7.8 Percentage of participants
|
15.6 Percentage of participants
|
|
Patient Rating of Overall Improvement at End of Study (Week 12)
No Improvement
|
2.0 Percentage of participants
|
1.0 Percentage of participants
|
|
Patient Rating of Overall Improvement at End of Study (Week 12)
Worse
|
0 Percentage of participants
|
1.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the FAS who took part in this evaluation.
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=102 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=96 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Very Good
|
52.0 Percentage of participants
|
56.3 Percentage of participants
|
|
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Good
|
34.3 Percentage of participants
|
26.0 Percentage of participants
|
|
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Satisfactory
|
4.9 Percentage of participants
|
8.3 Percentage of participants
|
|
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Poor
|
0 Percentage of participants
|
1.0 Percentage of participants
|
|
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
No Opinion
|
8.8 Percentage of participants
|
8.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Participants in the FAS who took part in this evaluation.
Outcome measures
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=102 Participants
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=96 Participants
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Patient Opinion of Local Tolerability
Excellent
|
53.9 Percentage of Participants
|
72.9 Percentage of Participants
|
|
Patient Opinion of Local Tolerability
Good
|
34.3 Percentage of Participants
|
15.6 Percentage of Participants
|
|
Patient Opinion of Local Tolerability
Acceptable despite minor irritation
|
7.8 Percentage of Participants
|
11.5 Percentage of Participants
|
|
Patient Opinion of Local Tolerability
Less acceptable due to continuous irritation
|
2.9 Percentage of Participants
|
0 Percentage of Participants
|
|
Patient Opinion of Local Tolerability
No opinion
|
1.0 Percentage of Participants
|
0 Percentage of Participants
|
Adverse Events
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 participants at risk
Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 participants at risk
Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
Other adverse events
| Measure |
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
n=106 participants at risk
Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
|
Metronidazole (Metrogel) Plus Doxycycline (Oracea)
n=101 participants at risk
Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
|
|---|---|---|
|
Ear and labyrinth disorders
Ear congestion
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Endocrine disorders
Diabetes mellitus
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.94%
1/106 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106 • Number of events 1
|
2.0%
2/101 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/106 • Number of events 3
|
2.0%
2/101 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/106 • Number of events 2
|
0.00%
0/101
|
|
Gastrointestinal disorders
Toothache
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
General disorders
Application site oedema
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Application site pruritus
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/106
|
2.0%
2/101 • Number of events 2
|
|
General disorders
Application site urticaria
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
General disorders
Application site exfoliation
|
0.00%
0/106
|
3.0%
3/101 • Number of events 7
|
|
General disorders
Application site burn
|
0.94%
1/106 • Number of events 2
|
0.00%
0/101
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.94%
1/106 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Infections and infestations
Herpes zoster
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Infections and infestations
Influenza
|
0.94%
1/106 • Number of events 1
|
2.0%
2/101 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
4/106 • Number of events 4
|
4.0%
4/101 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Infections and infestations
Sinusitis
|
1.9%
2/106 • Number of events 2
|
2.0%
2/101 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Infections and infestations
Upper respiratory tract infection
|
0.94%
1/106 • Number of events 1
|
2.0%
2/101 • Number of events 2
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
Food poisoning
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.94%
1/106 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/106
|
0.99%
1/101 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.8%
3/106 • Number of events 3
|
5.0%
5/101 • Number of events 8
|
|
Nervous system disorders
Nerve compression
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Psychiatric disorders
Anxiety
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.94%
1/106 • Number of events 1
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/106
|
2.0%
2/101 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/106
|
0.99%
1/101 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.94%
1/106 • Number of events 1
|
0.00%
0/101
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/106
|
0.99%
1/101 • Number of events 2
|
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