Papulopustular Rosacea
Conditions
Keywords
rosacea, papulopustular, azelaic acid, foam
Brief summary
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.
Interventions
DRUGAzelaic acid
15% foam to be applied topically twice daily
DRUGVehicle foam
Active-ingredient-free vehicle to be applied topically twice daily
Sponsors
Bayer
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male and female patient at least 18 years of age * signed informed consent * Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia * Ability and willingness to accept and comply with treatment and required medical examinations
Exclusion criteria
* Known non-responders to azelaic acid * Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea * Presence of dermatoses that could interfere with the rosacea diagnosis * Treatment with isotretinoin in the six months prior to randomization * Treatment of the face with topical retinoids during the two weeks prior to randomization * Treatment with oral antibiotics during the four weeks prior to randomization * Treatment with topical antibiotics * Treatment with systemic corticosteroids during 4 weeks prior to randomization * Treatment of the face with topical corticosteroids during 2 weeks prior to randomization * Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization * Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization * Use of a sauna during 2 weeks prior to randomization and during the study * Facial laser surgery for telangiectasia during 6 weeks prior to randomization * Planned concurrent use of any treatment other than study medication that affects rosacea * History of hypersensitivity to propylene glycol or any other ingredient of the study drugs * Participation in another clinical trial during the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | Baseline and End of Study (Week 12) | — |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | At End of Study (Week 12) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Baseline and End of Study (Week 12) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). |
| Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
| Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
| Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe |
| Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe |
| Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | — |
| Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe |
| Investigator's Rating of Overall Improvement at End of Study | At End of Study (Week 12) | Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration |
| Patients' Rating of Overall Improvement at End of Study | At End of Study (Week 12) | Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse |
| Patients' Opinion on Cosmetic Acceptability at End of Study | At End of Study (Week 12) | Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion |
| Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | At Weeks 4, 8 and 12 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).). |
| Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2). |
| Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe |
| Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | At Weeks 4, 8, 12 and End of Study (LOCF) | — |
| Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Baseline and Weeks 4, 8 and 12 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) Participants received azelaic acid foam, 15% topically twice daily for 12 weeks | 41 |
| Vehicle Foam Participants received vehicle foam topically twice daily for 12 weeks | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | noncompliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Azelaic Acid Foam, 15% (BAY39-6251) | Vehicle Foam | Total |
|---|---|---|---|
| Age, Continuous | 49.4 Years STANDARD_DEVIATION 11.9 | 51.5 Years STANDARD_DEVIATION 12.5 | 50.5 Years STANDARD_DEVIATION 12.2 |
| Erythema intensity score at baseline | 3.1 Scores on a scale STANDARD_DEVIATION 0.5 | 3.0 Scores on a scale STANDARD_DEVIATION 0.5 | 3.0 Scores on a scale STANDARD_DEVIATION 0.5 |
| Investigator's Global Assessment (IGA) score at Baseline | 4.0 Scores on a scale STANDARD_DEVIATION 0.9 | 3.9 Scores on a scale STANDARD_DEVIATION 0.9 | 3.9 Scores on a scale STANDARD_DEVIATION 0.9 |
| Number of inflammatory lesions per participant at Baseline | 18.0 Inflammatory lesions STANDARD_DEVIATION 10.61 | 17.6 Inflammatory lesions STANDARD_DEVIATION 8.36 | 17.8 Inflammatory lesions STANDARD_DEVIATION 9.48 |
| Previous duration of rosacea | 88.5 Months STANDARD_DEVIATION 63.8 | 91.9 Months STANDARD_DEVIATION 77 | 90.2 Months STANDARD_DEVIATION 70.4 |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 41 | 10 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
Primary
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: Baseline and End of Study (Week 12)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Improved | 61.0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | No change | 36.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Worse | 2.4 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Improved | 47.6 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | No change | 45.2 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Worse | 7.1 Percentage of participants |
Primary
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)
Time frame: Baseline and End of Study (Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | -11.7 Inflammatory lesions | Standard Deviation 8.53 |
| Vehicle Foam | Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) | -10.8 Inflammatory lesions | Standard Deviation 7.8 |
Primary
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time frame: At End of Study (Week 12)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | 46.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | 47.6 Percentage of participants |
Secondary
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -0.3 Scores on a scale | Standard Deviation 0.6 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -0.6 Scores on a scale | Standard Deviation 0.7 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -0.8 Scores on a scale | Standard Deviation 0.8 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -0.8 Scores on a scale | Standard Deviation 0.8 |
| Vehicle Foam | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -0.6 Scores on a scale | Standard Deviation 0.9 |
| Vehicle Foam | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -0.4 Scores on a scale | Standard Deviation 0.6 |
| Vehicle Foam | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -0.7 Scores on a scale | Standard Deviation 1 |
| Vehicle Foam | Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -0.5 Scores on a scale | Standard Deviation 0.8 |
Secondary
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -1.0 Scores on a scale | Standard Deviation 1.2 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -1.6 Scores on a scale | Standard Deviation 1.3 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -2.1 Scores on a scale | Standard Deviation 1.2 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -2.0 Scores on a scale | Standard Deviation 1.3 |
| Vehicle Foam | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -1.7 Scores on a scale | Standard Deviation 1.4 |
| Vehicle Foam | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -0.7 Scores on a scale | Standard Deviation 1.1 |
| Vehicle Foam | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -1.9 Scores on a scale | Standard Deviation 1.3 |
| Vehicle Foam | Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -1.3 Scores on a scale | Standard Deviation 1.4 |
Secondary
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | 0.0 Scores on a scale | Standard Deviation 0.3 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -0.1 Scores on a scale | Standard Deviation 0.3 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -0.2 Scores on a scale | Standard Deviation 0.4 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -0.1 Scores on a scale | Standard Deviation 0.4 |
| Vehicle Foam | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -0.2 Scores on a scale | Standard Deviation 0.4 |
| Vehicle Foam | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -0.1 Scores on a scale | Standard Deviation 0.4 |
| Vehicle Foam | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -0.3 Scores on a scale | Standard Deviation 0.5 |
| Vehicle Foam | Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -0.3 Scores on a scale | Standard Deviation 0.5 |
Secondary
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: Baseline and Weeks 4, 8 and 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-Improved | 63.2 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-No change | 34.2 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-Worse | 2.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-Improved | 35.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-No change | 59.0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-Worse | 5.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-Improved | 50.0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-No change | 50.0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-Worse | 0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-No change | 40.5 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-Worse | 5.3 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-No change | 37.1 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-Improved | 54.3 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 12-Worse | 8.6 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-Improved | 48.6 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-Improved | 42.1 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 8-Worse | 10.8 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Week 4-No change | 52.6 Percentage of participants |
Secondary
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-Improved | 5.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-Worse | 2.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-Worse | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-No change | 92.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-Improved | 10.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-No change | 89.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-Improved | 15.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-No change | 84.2 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-Worse | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-Improved | 14.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-No change | 85.4 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-Worse | 0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-No change | 76.2 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-No change | 86.8 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-Improved | 28.6 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-Worse | 2.6 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-No change | 73.0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-Improved | 23.8 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-Improved | 10.5 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-No change | 71.4 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-Worse | 0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-Improved | 27.0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-Worse | 0 Percentage of participants |
| Vehicle Foam | Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-Worse | 0 Percentage of participants |
Secondary
Investigator's Rating of Overall Improvement at End of Study
Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Time frame: At End of Study (Week 12)
Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Investigator's Rating of Overall Improvement at End of Study | Marked Improvement | 23.7 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Investigator's Rating of Overall Improvement at End of Study | No Improvement | 7.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Investigator's Rating of Overall Improvement at End of Study | Moderate Improvement | 31.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Investigator's Rating of Overall Improvement at End of Study | Deterioration | 2.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Investigator's Rating of Overall Improvement at End of Study | Excellent Improvement | 34.2 Percentage of participants |
| Vehicle Foam | Investigator's Rating of Overall Improvement at End of Study | Deterioration | 2.5 Percentage of participants |
| Vehicle Foam | Investigator's Rating of Overall Improvement at End of Study | Excellent Improvement | 40.0 Percentage of participants |
| Vehicle Foam | Investigator's Rating of Overall Improvement at End of Study | Marked Improvement | 17.5 Percentage of participants |
| Vehicle Foam | Investigator's Rating of Overall Improvement at End of Study | Moderate Improvement | 27.5 Percentage of participants |
| Vehicle Foam | Investigator's Rating of Overall Improvement at End of Study | No Improvement | 12.5 Percentage of participants |
Secondary
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | 6.3 Inflammatory lesions | Standard Deviation 10.64 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | 9.1 Inflammatory lesions | Standard Deviation 7.93 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | 6.8 Inflammatory lesions | Standard Deviation 7.59 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | 4.3 Inflammatory lesions | Standard Deviation 5.86 |
| Vehicle Foam | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | 4.6 Inflammatory lesions | Standard Deviation 5.47 |
| Vehicle Foam | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | 6.8 Inflammatory lesions | Standard Deviation 8.46 |
| Vehicle Foam | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | 6.6 Inflammatory lesions | Standard Deviation 5.57 |
| Vehicle Foam | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | 11.7 Inflammatory lesions | Standard Deviation 9.23 |
Secondary
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Time frame: Baseline and Weeks 4, 8 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 4 | -7.5 Inflammatory lesions | Standard Deviation 4.68 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 8 | -9.9 Inflammatory lesions | Standard Deviation 5.88 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 12 | -12.4 Inflammatory lesions | Standard Deviation 8.38 |
| Vehicle Foam | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 4 | -5.8 Inflammatory lesions | Standard Deviation 4.95 |
| Vehicle Foam | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 8 | -10.3 Inflammatory lesions | Standard Deviation 6.62 |
| Vehicle Foam | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Week 12 | -12.4 Inflammatory lesions | Standard Deviation 7.26 |
Secondary
Patients' Opinion on Cosmetic Acceptability at End of Study
Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Time frame: At End of Study (Week 12)
Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Opinion on Cosmetic Acceptability at End of Study | Good | 36.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Opinion on Cosmetic Acceptability at End of Study | Poor | 5.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Opinion on Cosmetic Acceptability at End of Study | Very Good | 42.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Opinion on Cosmetic Acceptability at End of Study | No Opinion | 5.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Opinion on Cosmetic Acceptability at End of Study | Satisfactory | 10.5 Percentage of participants |
| Vehicle Foam | Patients' Opinion on Cosmetic Acceptability at End of Study | No Opinion | 12.5 Percentage of participants |
| Vehicle Foam | Patients' Opinion on Cosmetic Acceptability at End of Study | Very Good | 35.0 Percentage of participants |
| Vehicle Foam | Patients' Opinion on Cosmetic Acceptability at End of Study | Good | 37.5 Percentage of participants |
| Vehicle Foam | Patients' Opinion on Cosmetic Acceptability at End of Study | Satisfactory | 5.0 Percentage of participants |
| Vehicle Foam | Patients' Opinion on Cosmetic Acceptability at End of Study | Poor | 10.0 Percentage of participants |
Secondary
Patients' Rating of Overall Improvement at End of Study
Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Time frame: At End of Study (Week 12)
Population: All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Rating of Overall Improvement at End of Study | Excellent Improvement | 36.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Rating of Overall Improvement at End of Study | Fair Improvement | 21.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Rating of Overall Improvement at End of Study | Good Improvement | 28.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Rating of Overall Improvement at End of Study | Worse | 7.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Patients' Rating of Overall Improvement at End of Study | No Improvement | 5.3 Percentage of participants |
| Vehicle Foam | Patients' Rating of Overall Improvement at End of Study | Worse | 7.5 Percentage of participants |
| Vehicle Foam | Patients' Rating of Overall Improvement at End of Study | Fair Improvement | 22.5 Percentage of participants |
| Vehicle Foam | Patients' Rating of Overall Improvement at End of Study | Good Improvement | 22.5 Percentage of participants |
| Vehicle Foam | Patients' Rating of Overall Improvement at End of Study | No Improvement | 20.0 Percentage of participants |
| Vehicle Foam | Patients' Rating of Overall Improvement at End of Study | Excellent Improvement | 27.5 Percentage of participants |
Secondary
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-clear or almost clear | 18.4 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-clear or almost clear | 13.2 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 42.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 51.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 34.2 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 36.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 5.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-clear or almost clear | 5.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-clear or almost clear | 17.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 42.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 41.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 12.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 34.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 7.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 7.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 30.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 4.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-clear or almost clear | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 50.0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 7.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-clear or almost clear | 10.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 32.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 45.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 10.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-clear or almost clear | 25.7 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 22.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 45.7 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 5.7 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-clear or almost clear | 21.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 21.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 52.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 42.1 Percentage of participants |
Secondary
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).
Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | 73.7 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | 38.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | 70.7 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | 55.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | 54.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | 51.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | 34.2 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | 62.9 Percentage of participants |
Secondary
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).).
Time frame: At Weeks 4, 8 and 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 4 | 20.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 8 | 36.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 12 | 47.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 4 | 13.2 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 8 | 35.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | Week 12 | 54.3 Percentage of participants |
Secondary
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 26.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-minimal | 36.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 24.4 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-clear | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-minimal | 20.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 17.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild to moderate | 23.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 30.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate to severe | 7.7 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-clear | 7.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-minimal | 28.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 18.4 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild to moderate | 21.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 15.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate to severe | 7.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-clear | 10.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-minimal | 36.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild to moderate | 21.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate to severe | 5.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-clear | 9.8 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild to moderate | 19.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate to severe | 7.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 2.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 16.2 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild to moderate | 20.0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 8.6 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-clear | 16.7 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild to moderate | 16.2 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-minimal | 31.0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate to severe | 14.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild to moderate | 19.0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 21.6 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate to severe | 8.6 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-clear | 2.6 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate to severe | 8.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-minimal | 10.5 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 11.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 21.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 2.7 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild to moderate | 21.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 26.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-clear | 17.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate to severe | 13.2 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 5.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-minimal | 37.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-clear | 8.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 7.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-minimal | 27.0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 8.6 Percentage of participants |
Secondary
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-none | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 35.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 64.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-none | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 42.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 57.9 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-none | 2.6 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 42.1 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 55.3 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 0 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-none | 2.4 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 41.5 Percentage of participants |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 56.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-moderate | 38.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-none | 2.6 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-mild | 42.1 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-none | 2.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-moderate | 55.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-mild | 59.5 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4-severe | 0 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-mild | 62.9 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-none | 5.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study-none | 2.4 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-mild | 56.8 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12-moderate | 34.3 Percentage of participants |
| Vehicle Foam | Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8-moderate | 37.8 Percentage of participants |
Secondary
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Time frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azelaic Acid Foam, 15% (BAY39-6251) | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -49.5 Percent change in Inflammatory lesions | Standard Deviation 23.68 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -75.1 Percent change in Inflammatory lesions | Standard Deviation 33.8 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -62.7 Percent change in Inflammatory lesions | Standard Deviation 29.82 |
| Azelaic Acid Foam, 15% (BAY39-6251) | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -71.2 Percent change in Inflammatory lesions | Standard Deviation 36.42 |
| Vehicle Foam | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 8 | -62.8 Percent change in Inflammatory lesions | Standard Deviation 27.71 |
| Vehicle Foam | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 4 | -37.7 Percent change in Inflammatory lesions | Standard Deviation 36.7 |
| Vehicle Foam | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | End of Study | -65.3 Percent change in Inflammatory lesions | Standard Deviation 40.11 |
| Vehicle Foam | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Week 12 | -74.8 Percent change in Inflammatory lesions | Standard Deviation 32.4 |