Rosacea
Conditions
Brief summary
To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
Interventions
DRUGAzelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)
Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing
Azelaic Acid Cream 20%
Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser
Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser
DRUGMetronidazole Emulsion
Metronidazole Emulsion 0.75%
DRUGMetronidazole Lotion
Metronidazole Lotion 0,75%
Brimonidine Tartrate Gel 0.33%
Sponsors
Bayer
LEO Pharma
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients of at least 18 years of age at index date * At least one prescription for a topical rosacea treatments: Azelaic Acid Gel, Azelaic Acid Cream, Metronidazole Gel, Metronidazole Cream, Metronidazole Emulsion, Metronidazole Lotion, Brimonidine Tartrate Gel * At least one medical record with a diagnosis code for rosacea (ICD-9: 695.3) * At least 6 months of data history prior to the index date * Had at least one encounter at the Reliant Medical Group within 3 months prior to 01 January 2015
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments | Rosacea treatment in the past 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported likelihood of switching to a topical rosacea treatments | Rosacea treatment in the past 4 weeks | 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 |
| Quality of life | Rosacea treatment in the past 4 weeks | 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 |
| Treatment satisfaction | Rosacea treatment in the past 4 weeks | 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 |
| Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment | Rosacea treatment in the past 4 weeks | Extracted from the Rosacea Treatment Preference Questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographics and clinical characteristics: Rosacea treatment-related adverse events | Retrospective database analysis: encompassing patient data from up to 5 years | 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) |
| Baseline demographics and clinical characteristics: Age | Retrospective database analysis: encompassing patient data from up to 5 years | Assessed from retrospective analysis of electronic medical records |
| Self-reported adverse events associated with patients' satisfaction/dissatisfaction | Rosacea treatment in the past 4 weeks | 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 |
| Current and past medication use | Retrospective database analysis: encompassing patient data from up to 5 years | 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 |
| Baseline demographics and clinical characteristics: Gender | Retrospective database analysis: encompassing patient data from up to 5 years | Assessed from retrospective analysis of electronic medical records |
| Baseline demographics and clinical characteristics: Insurance type | Retrospective database analysis: encompassing patient data from up to 5 years | Assessed from retrospective analysis of electronic medical records |
| Baseline demographics and clinical characteristics: Charlson Comorbidity Index (CCI) | Retrospective database analysis: encompassing patient data from up to 5 years | Assessed from retrospective analysis of electronic medical records |
| Baseline demographics and clinical characteristics: Rosacea-relevant comorbidities and complications | Retrospective database analysis: encompassing patient data from up to 5 years | 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) |
Countries
United States
Outcome results
None listed