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| ID | Type | Description | Link |
|---|---|---|---|
| 1402604 | Other Identifier | Intendis GmbH | |
| 256-0024 | Other Identifier | Intendis GmbH |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea) | Experimental | Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks |
|
| Metronidazole (Metrogel) plus Doxycycline (Oracea) | Active Comparator | Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic acid (Finacea, BAY39-6251) | Drug | Participants received topical azelaic acid gel 15% twice daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Opinion of Local Tolerability | Week 12 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20645521 | Result | Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Metronidazole (Metrogel) Plus Doxycycline (Oracea) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Metronidazole (Metrogel) | Drug | Participants received topical metronidazole 1% gel once daily for 12 weeks |
|
| Doxycycline (Oracea) | Drug | Participants received systemic doxycycline 40 mg once daily for 12 week |
|
| Baseline and Week 4, 6, 8 and 12 |
| 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) | Baseline and Week 2, 4, 6, 8 and 12 |
| 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) | 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). | Weeks 2, 4, 6, 8 and 12 |
| 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) | Weeks 2, 4, 6, 8 and 12 |
| 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). | At Week 2 |
| 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). | At Week 4 |
| 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). | At Week 6 |
| 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). | At Week 8 |
| 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). | At Week 12 |
| 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 |
| Denver |
| Colorado |
| 80209 |
| United States |
| West Palm Beach | Florida | 33401 | United States |
| Boston | Massachusetts | 02114-2517 | United States |
| Warren | Michigan | 48088 | United States |
| Fridley | Minnesota | 55432 | United States |
| Henderson | Nevada | 89052 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Stony Brook | New York | 11790 | United States |
| Mason | Ohio | 45040 | United States |
| Portland | Oregon | 97223 | United States |
| Austin | Texas | 78759 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77056 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Norfolk | Virginia | 23507 | United States |
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 (refer to Detailed Description field in Protocol section for more information). | Number | Participants |
| |||||||||||||||
| Number of lesions at Baseline | Mean | Standard Deviation | Lesions |
| |||||||||||||||
| Previous duration of rosacea | Mean | Standard Deviation | Months |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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) | Full analysis set (FAS) | Posted | Mean | Standard Deviation | Inflammatory lesions | Baseline and Week 2 |
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| Secondary | Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) | FAS | Posted | Mean | Standard Deviation | Inflammatory lesions | Week 2, 4, 6, 8 and 12 |
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| 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) | FAS | Posted | Mean | Standard Deviation | Inflammatory lesions | Baseline and Week 4, 6, 8 and 12 |
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| 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) | FAS | Posted | Mean | Standard Deviation | Percent of inflammatory lesions | Baseline and Week 2, 4, 6, 8 and 12 |
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| 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) | FAS | Posted | Number | Percentage of participants | Baseline and Weeks 2, 4, 6, 8 and 12 |
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| 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). | FAS | Posted | Number | Percentage of participants | Weeks 2, 4, 6, 8 and 12 |
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| 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) | FAS | Posted | Number | Percentage of participants | Weeks 2, 4, 6, 8 and 12 |
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| 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). | FAS | Posted | Number | Percentage of participants | At Week 2 |
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| 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). | FAS | Posted | Number | Percentage of participants | At Week 4 |
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| 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). | FAS | Posted | Number | Percentage of participants | At Week 6 |
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| 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). | FAS | Posted | Number | Percentage of participants | At Week 8 |
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| 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). | FAS | Posted | Number | Percentage of participants | At Week 12 |
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| Secondary | Investigator Rating of Overall Improvement at End of Study (Week 12) | Participants in the FAS who took part in this evaluation. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Patient Rating of Overall Improvement at End of Study (Week 12) | Participants in the FAS who took part in this evaluation. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) | Participants in the FAS who took part in this evaluation. | Posted | Number | Percentage of participants | Week 12 |
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| Other Pre-specified | Patient Opinion of Local Tolerability | Participants in the FAS who took part in this evaluation. | Posted | Number | Percentage of Participants | Week 12 |
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| 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 (Finacea, BAY39-6251) Plus Doxycycline (Oracea) | Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks | 0 | 106 | 29 | 106 | ||
| EG001 | Metronidazole (Metrogel) Plus Doxycycline (Oracea) | Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks | 1 | 101 | 33 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear congestion | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Diabetes mellitus | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Application site oedema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Chills | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Application site urticaria | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Application site exfoliation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Application site burn | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Food poisoning | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Elective surgery | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Intendis GmbH | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C010038 | azelaic acid |
| D008795 | Metronidazole |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Male |
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| IGA Score 5 - Moderate to Severe |
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| IGA Score 6- Severe |
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