Not provided
Not provided
Not provided
Not provided
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
To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosacea treated patients | Patients using topical rosacea treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251) | Drug | Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments | Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning not at all important and 10 meaning extremely important | Rosacea treatment in the past 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported likelihood of switching to a topical rosacea treatments | Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning not at all likely and 10 meaning extremely likely | Rosacea treatment in the past 4 weeks |
| Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline demographics and clinical characteristics: Age | Assessed from retrospective analysis of electronic medical records | Retrospective database analysis: encompassing patient data from up to 5 years |
| Baseline demographics and clinical characteristics: Gender |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are using topical rosacea treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States |
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Azelaic Acid Cream | Drug | Azelaic Acid Cream 20% |
|
| Metronidazole gel | Drug | Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser |
|
| Metronidazole cream | Drug | Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser |
|
| Metronidazole Emulsion | Drug | Metronidazole Emulsion 0.75% |
|
| Metronidazole Lotion | Drug | Metronidazole Lotion 0,75% |
|
| Brimonidine Tartrate Gel | Drug | Brimonidine Tartrate Gel 0.33% |
|
Measured using Dermatology Life Quality Index (DLQI): The DLQI consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, and school, personal relationships and treatment |
| Rosacea treatment in the past 4 weeks |
| Treatment satisfaction | Assessed by a score on the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). Scores will be standardized and expressed as a 0-100 standardized score | Rosacea treatment in the past 4 weeks |
| Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment | Extracted from the Rosacea Treatment Preference Questionnaire | Rosacea treatment in the past 4 weeks |
Assessed from retrospective analysis of electronic medical records |
| Retrospective database analysis: encompassing patient data from up to 5 years |
| Baseline demographics and clinical characteristics: Insurance type | Assessed from retrospective analysis of electronic medical records | Retrospective database analysis: encompassing patient data from up to 5 years |
| Baseline demographics and clinical characteristics: Charlson Comorbidity Index (CCI) | Assessed from retrospective analysis of electronic medical records | Retrospective database analysis: encompassing patient data from up to 5 years |
| Baseline demographics and clinical characteristics: Rosacea-relevant comorbidities and complications | Assessed from retrospective analysis of electronic medical records: Blepharitis (ICD-9: 373.0) Conjunctivitis (ICD-9: 372.0-372.2) Corneal neovascularization / keratitis (ICD-9: 370) Depression (ICD-9: 296.2-296.3) Migraine (ICD-9: 346) | Retrospective database analysis: encompassing patient data from up to 5 years |
| Baseline demographics and clinical characteristics: Rosacea treatment-related adverse events | Assessed from retrospective analysis of electronic medical records: Burning/stinging/tingling (ICD-9: 782.0) Pruritus (ICD-9: 698) Scaling/dry skin/xerosis (ICD-9: 692.9, 706.8) Erythema/irritation (ICD-9: 695) Contact dermatitis (ICD-9: 692.3, 692.8, 692.9) Facial edema (ICD-9: 782.3) Acne (ICD-9: 706.1) | Retrospective database analysis: encompassing patient data from up to 5 years |
| Current and past medication use | Assessed from retrospective analysis of electronic medical records Including: azelaic acid gel, azelaic acid cream, metronidazole gel, metronidazole cream, metronidazole lotion, metronidazole emulsion, brimonidine tartrate gel | Retrospective database analysis: encompassing patient data from up to 5 years |
| Self-reported adverse events associated with patients' satisfaction/dissatisfaction | Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning no pain/discomfort and 10 meaning unbearable pain/discomfort | Rosacea treatment in the past 4 weeks |