Papulopustular Rosacea
Conditions
Keywords
Rosacea
Brief summary
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
Detailed description
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction. Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).
Interventions
DRUGAzelaic acid (Finacea, BAY39-6251)
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
DRUGMetronidazole (Metrogel)
Participants received topical metronidazole 1% gel once daily for 12 weeks
DRUGDoxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week
Sponsors
Bayer
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Moderate papulopustular rosacea (IGA\>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
Exclusion criteria
* Sensitivity to any of the treatments used * Co-existing conditions that would unfavorably influence the course of the disease * Pregnant or lactating women * Severe rosacea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) | Baseline and Week 2 | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2, 4, 6, 8 and 12 | — |
| Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Baseline and Week 4, 6, 8 and 12 | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) |
| Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Baseline and Week 2, 4, 6, 8 and 12 | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) |
| 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) | Baseline and Weeks 2, 4, 6, 8 and 12 | — |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Weeks 2, 4, 6, 8 and 12 | 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). |
| Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Weeks 2, 4, 6, 8 and 12 | 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) |
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | At Week 2 | 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). |
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | At Week 6 | 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). |
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | At Week 8 | 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). |
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | At Week 12 | 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). |
| Investigator Rating of Overall Improvement at End of Study (Week 12) | Week 12 | — |
| Patient Rating of Overall Improvement at End of Study (Week 12) | Week 12 | — |
| Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Week 12 | — |
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | At Week 4 | 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). |
Other
| Measure | Time frame |
|---|---|
| Patient Opinion of Local Tolerability | Week 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 106 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks | 101 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | patient left country | 0 | 1 |
| Overall Study | patient moved out of state | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Total | Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) |
|---|---|---|---|
| Age, Continuous | 48.4 Years STANDARD_DEVIATION 11.5 | 49.4 Years STANDARD_DEVIATION 12.2 | 50.4 Years STANDARD_DEVIATION 12.7 |
| Investigator's Global Assessment (IGA) score at Baseline IGA Score 4 - Moderate | 76 Participants | 155 Participants | 79 Participants |
| Investigator's Global Assessment (IGA) score at Baseline IGA Score 5 - Moderate to Severe | 22 Participants | 48 Participants | 26 Participants |
| Investigator's Global Assessment (IGA) score at Baseline IGA Score 6- Severe | 3 Participants | 4 Participants | 1 Participants |
| Number of lesions at Baseline | 21.9 Lesions STANDARD_DEVIATION 10.5 | 21.3 Lesions STANDARD_DEVIATION 10.76 | 20.6 Lesions STANDARD_DEVIATION 11.01 |
| Previous duration of rosacea | 134.9 Months STANDARD_DEVIATION 107.2 | 132.8 Months STANDARD_DEVIATION 117 | 130.8 Months STANDARD_DEVIATION 126.1 |
| Sex: Female, Male Female | 69 Participants | 136 Participants | 67 Participants |
| Sex: Female, Male Male | 32 Participants | 71 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 106 | 33 / 101 |
| serious Total, serious adverse events | 0 / 106 | 1 / 101 |
Outcome results
Primary
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Time frame: Baseline and Week 2
Population: Full analysis set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) | -9.4 Inflammatory lesions | Standard Deviation 9.38 |
p-value: 0.0903ANCOVA
Secondary
Investigator Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Population: Participants in the FAS who took part in this evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Marked Improvement | 35.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | No change | 4.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Moderate Improvement | 12.6 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Deterioration | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Excellent Improvement | 46.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Deterioration | 0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Excellent Improvement | 42.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Marked Improvement | 34.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | Moderate Improvement | 17.5 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Investigator Rating of Overall Improvement at End of Study (Week 12) | No change | 6.2 Percentage of participants |
Secondary
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Time frame: Baseline and Week 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Week 6 | -14.8 Inflammatory lesions | Standard Deviation 9.2 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Week 12 | -16.2 Inflammatory lesions | Standard Deviation 10.01 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Week 4 | -12.4 Inflammatory lesions | Standard Deviation 9.23 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Week 8 | -15.6 Inflammatory lesions | Standard Deviation 9.82 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | Week 6 | -14.1 Inflammatory lesions | Standard Deviation 9.32 |
Secondary
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Week 2, 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | 7.4 Inflammatory lesions | Standard Deviation 7.29 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | 5.1 Inflammatory lesions | Standard Deviation 6.28 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | 5.9 Inflammatory lesions | Standard Deviation 6.28 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | 4.4 Inflammatory lesions | Standard Deviation 6.51 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | 10.1 Inflammatory lesions | Standard Deviation 8.7 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | 5.7 Inflammatory lesions | Standard Deviation 7.22 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | 12.5 Inflammatory lesions | Standard Deviation 9.86 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | 9.5 Inflammatory lesions | Standard Deviation 8.09 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | 7.8 Inflammatory lesions | Standard Deviation 7.18 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | 6.4 Inflammatory lesions | Standard Deviation 7.02 |
Secondary
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Time frame: Week 12
Population: Participants in the FAS who took part in this evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Good | 34.3 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Poor | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Satisfactory | 4.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | No Opinion | 8.8 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Very Good | 52.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | No Opinion | 8.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Very Good | 56.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Good | 26.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Satisfactory | 8.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Poor | 1.0 Percentage of participants |
Secondary
Patient Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Population: Participants in the FAS who took part in this evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Excellent Improvement | 51.0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | No Improvement | 2.0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Good Improvement | 39.2 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Worse | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Fair Improvement | 7.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Worse | 1.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Excellent Improvement | 49.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Fair Improvement | 15.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | No Improvement | 1.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Rating of Overall Improvement at End of Study (Week 12) | Good Improvement | 33.3 Percentage of participants |
Secondary
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)
Time frame: Baseline and Weeks 2, 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 65.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 77.2 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 47.5 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 17.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 81.2 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 64.4 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 40.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 91.1 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 78.2 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 43.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 90.1 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 87.1 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 55.4 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 91.1 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | 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 | 85.1 Percentage of participants |
Secondary
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
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)
Time frame: Weeks 2, 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | 55.7 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | 72.6 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | 60.4 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | 78.3 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | 32.1 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | 72.3 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | 27.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | 44.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | 53.5 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | 59.4 Percentage of participants |
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
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).
Time frame: Weeks 2, 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | 52.5 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | 7.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | 26.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | 27.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | 39.6 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
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).
Time frame: At Week 12
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 2 - Mild | 16.0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 4 - Moderate | 6.6 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 1 - Minimal | 32.1 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 5 - Moderate to severe | 1.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 3 - Mild to moderate | 12.3 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 6 - Severe | 0.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 0 - Clear | 30.2 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 6 - Severe | 0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 0 - Clear | 22.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 1 - Minimal | 29.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 2 - Mild | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 3 - Mild to moderate | 13.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 4 - Moderate | 10.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | 5 - Moderate to severe | 3.0 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
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).
Time frame: At Week 2
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 2 - Mild | 18.9 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 4 - Moderate | 25.5 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 1 - Minimal | 12.3 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 5 - Moderate to severe | 9.4 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 3 - Mild to moderate | 33.0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 6 - Severe | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 0 - Clear | 0.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 6 - Severe | 2.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 0 - Clear | 1.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 1 - Minimal | 6.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 2 - Mild | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 3 - Mild to moderate | 31.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 4 - Moderate | 27.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | 5 - Moderate to severe | 10.9 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
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).
Time frame: At Week 4
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 4 - Moderate | 15.1 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 0 - Clear | 7.5 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 1 - Minimal | 24.5 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 5 - Moderate to severe | 4.7 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 3 - Mild to moderate | 24.5 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 6 - Severe | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 2 - Mild | 23.6 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 6 - Severe | 1.0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 1 - Minimal | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 2 - Mild | 17.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 3 - Mild to moderate | 23.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 4 - Moderate | 20.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 5 - Moderate to severe | 9.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | 0 - Clear | 6.9 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
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).
Time frame: At Week 6
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 2 - Mild | 15.1 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 4 - Moderate | 11.3 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 1 - Minimal | 26.4 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 5 - Moderate to severe | 3.8 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 3 - Mild to moderate | 24.5 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 6 - Severe | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 0 - Clear | 18.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 6 - Severe | 0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 0 - Clear | 9.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 1 - Minimal | 17.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 2 - Mild | 25.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 3 - Mild to moderate | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 4 - Moderate | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | 5 - Moderate to severe | 6.9 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
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).
Time frame: At Week 8
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 2 - Mild | 21.7 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 4 - Moderate | 10.4 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 1 - Minimal | 32.1 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 5 - Moderate to severe | 2.8 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 3 - Mild to moderate | 14.2 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 6 - Severe | 0 Percentage of participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 0 - Clear | 18.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 6 - Severe | 0 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 0 - Clear | 13.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 1 - Minimal | 25.7 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 2 - Mild | 19.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 3 - Mild to moderate | 23.8 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 4 - Moderate | 12.9 Percentage of participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | 5 - Moderate to severe | 4.0 Percentage of participants |
Secondary
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Time frame: Baseline and Week 2, 4, 6, 8 and 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | 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 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 12 | -75.1 Percent of inflammatory lesions | Standard Deviation 27.25 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 2 | -43.0 Percent of inflammatory lesions | Standard Deviation 35.68 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 4 | -56.9 Percent of inflammatory lesions | Standard Deviation 31.5 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 6 | -64.5 Percent of inflammatory lesions | Standard Deviation 29 |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | Week 8 | -71.6 Percent of inflammatory lesions | Standard Deviation 26.94 |
Other Pre-specified
Patient Opinion of Local Tolerability
Time frame: Week 12
Population: Participants in the FAS who took part in this evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Good | 34.3 Percentage of Participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Less acceptable due to continuous irritation | 2.9 Percentage of Participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Acceptable despite minor irritation | 7.8 Percentage of Participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | No opinion | 1.0 Percentage of Participants |
| Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Excellent | 53.9 Percentage of Participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | No opinion | 0 Percentage of Participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Excellent | 72.9 Percentage of Participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Good | 15.6 Percentage of Participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Acceptable despite minor irritation | 11.5 Percentage of Participants |
| Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Patient Opinion of Local Tolerability | Less acceptable due to continuous irritation | 0 Percentage of Participants |