Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid foam, 15% (BAY39-6251) | Experimental | Participants received azelaic acid foam, 15% topically twice daily for 12 weeks |
|
| Vehicle foam | Placebo Comparator | Participants received vehicle foam topically twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid | Drug | 15% foam to be applied topically twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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). | At End of Study (Week 12) |
| 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 | Baseline and End of Study (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | 80209 | United States | |||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Azelaic Acid Foam, 15% (BAY39-6251) | Participants received azelaic acid foam, 15% topically twice daily for 12 weeks |
| FG001 | Vehicle Foam | Participants received vehicle foam topically twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Azelaic Acid Foam, 15% (BAY39-6251) | Participants received azelaic acid foam, 15% topically twice daily for 12 weeks |
| BG001 | Vehicle Foam | Participants received vehicle foam topically twice daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | Inflammatory lesions | Baseline and End of Study (Week 12) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azelaic Acid Foam, 15% (BAY39-6251) | Participants received azelaic acid foam, 15% topically twice daily for 12 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | clinical-trials-contact@bayer.com |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C010038 | azelaic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle foam |
| Drug |
Active-ingredient-free vehicle to be applied topically twice daily |
|
| 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) |
| 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). | At Weeks 4, 8, 12 and End of Study (LOCF) |
| 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). | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
| 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 | At Weeks 4, 8, 12 and End of Study (LOCF) |
| 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 | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
| 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 | Baseline and Weeks 4, 8 and 12 |
| 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 | At Weeks 4, 8, 12 and End of Study (LOCF) |
| 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 | 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) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
| 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 | At End of Study (Week 12) |
| 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 | At End of Study (Week 12) |
| 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 | At End of Study (Week 12) |
| 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)."). | At Weeks 4, 8 and 12 |
| 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). | At Weeks 4, 8, 12 and End of Study (LOCF) |
| Olathe |
| Kansas |
| 66062 |
| United States |
| Henderson | Nevada | 89052 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Mason | Ohio | 45040 | United States |
| Austin | Texas | 78759 | United States |
| Norfolk | Virginia | 23507 | United States |
| Lack of Efficacy |
|
| Adverse Event |
|
| noncompliance |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Previous duration of rosacea | Mean | Standard Deviation | Months |
|
| Investigator's Global Assessment (IGA) score at Baseline | 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). | Mean | Standard Deviation | Scores on a scale |
|
| Number of inflammatory lesions per participant at Baseline | Mean | Standard Deviation | Inflammatory lesions |
|
| Erythema intensity score at baseline | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe | Mean | Standard Deviation | Scores on a scale |
|
| Counts |
|---|
| Participants |
|
|
| 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). | Posted | Number | Percentage of participants | At End of Study (Week 12) |
|
|
|
| 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 | Posted | Number | Percentage of participants | Baseline and End of Study (Week 12) |
|
|
|
| Secondary | Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Posted | Mean | Standard Deviation | Inflammatory lesions | At Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| Secondary | Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 | Posted | Mean | Standard Deviation | Inflammatory lesions | Baseline and Weeks 4, 8 and 12 |
|
|
|
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) | Posted | Mean | Standard Deviation | Percent change in Inflammatory lesions | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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). | Posted | Number | Percentage of participants | At Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | Posted | Number | Percentage of participants | At Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | Posted | Number | Percentage of participants | Baseline and Weeks 4, 8 and 12 |
|
|
|
| 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 | Posted | Number | Percentage of participants | At Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | Posted | Number | Percentage of participants | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 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 | All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases) | Posted | Number | Percentage of participants | At End of Study (Week 12) |
|
|
|
| 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 | All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases | Posted | Number | Percentage of participants | At End of Study (Week 12) |
|
|
|
| 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 | All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases | Posted | Number | Percentage of participants | At End of Study (Week 12) |
|
|
|
| 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)."). | Posted | Number | Percentage of participants | At Weeks 4, 8 and 12 |
|
|
|
| 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). | Posted | Number | Percentage of participants | At Weeks 4, 8, 12 and End of Study (LOCF) |
|
|
|
| 0 |
| 41 |
| 14 |
| 41 |
| EG001 | Vehicle Foam | Participants received vehicle foam topically twice daily for 12 weeks | 0 | 42 | 10 | 42 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Administration site reaction | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
A) Investigator shall provide Sponsor with intended publication 60 days upfront publication date, Sponsor has 30 d to comment, recommended changes shall not be unreasonably refused B) Sponsor has the right to ask Investigator to delay publication for a maximum of 90 days C) Investigative data will be pooled and published by Sponsor - no other publication without the consent of all parties prior to publication of the pooled data, or within 12 months after LPLV, whatever comes first
| Worse |
|
| Week 12 |
|
| End of Study |
|
| Week 12 |
|
| Week 12 |
|
| End of Study |
|
| Week 4-mild |
|
| Week 4-mild to moderate |
|
| Week 4-moderate |
|
| Week 4-moderate to severe |
|
| Week 4-severe |
|
| Week 8-clear |
|
| Week 8-minimal |
|
| Week 8-mild |
|
| Week 8-mild to moderate |
|
| Week 8-moderate |
|
| Week 8-moderate to severe |
|
| Week 8-severe |
|
| Week 12-clear |
|
| Week 12-minimal |
|
| Week 12-mild |
|
| Week 12-mild to moderate |
|
| Week 12-moderate |
|
| Week 12-moderate to severe |
|
| Week 12-severe |
|
| End of Study-clear |
|
| End of Study-minimal |
|
| End of Study-mild |
|
| End of Study-mild to moderate |
|
| End of Study-moderate |
|
| End of Study-moderate to severe |
|
| End of Study-severe |
|
| Week 12 |
|
| End of Study |
|
| Week 4-moderate |
|
| Week 4-severe |
|
| Week 8-clear or almost clear |
|
| Week 8-mild |
|
| Week 8-moderate |
|
| Week 8-severe |
|
| Week 12-clear or almost clear |
|
| Week 12-mild |
|
| Week 12-moderate |
|
| Week 12-severe |
|
| End of Study-clear or almost clear |
|
| End of Study-mild |
|
| End of Study-moderate |
|
| End of Study-severe |
|
| Week 12 |
|
| End of Study |
|
| Week 4-Worse |
|
| Week 8-Improved |
|
| Week 8-No change |
|
| Week 8-Worse |
|
| Week 12-Improved |
|
| Week 12-No change |
|
| Week 12-Worse |
|
| Week 4-moderate |
|
| Week 4-severe |
|
| Week 8-none |
|
| Week 8-mild |
|
| Week 8-moderate |
|
| Week 8-severe |
|
| Week 12-none |
|
| Week 12-mild |
|
| Week 12-moderate |
|
| Week 12-severe |
|
| End of Study-none |
|
| End of Study-mild |
|
| End of Study-moderate |
|
| End of Study-severe |
|
| Week 12 |
|
| End of Study |
|
| Week 4-Worse |
|
| Week 8-Improved |
|
| Week 8-No change |
|
| Week 8-Worse |
|
| Week 12-Improved |
|
| Week 12-No change |
|
| Week 12-Worse |
|
| End of Study-Improved |
|
| End of Study-No change |
|
| End of Study-Worse |
|
| Moderate Improvement |
|
| No Improvement |
|
| Deterioration |
|
| Fair Improvement |
|
| No Improvement |
|
| Worse |
|
| Satisfactory |
|
| Poor |
|
| No Opinion |
|
| Week 12 |
|
| Week 12 |
|
| End of Study |
|