Preferences & Treatment Satisfaction Drivers in Rosacea Patients
Study Details
Study Description
Brief Summary
To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rosacea treated patients Patients using topical rosacea treatment |
Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)
Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing
Drug: Azelaic Acid Cream
Azelaic Acid Cream 20%
Drug: Metronidazole gel
Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser
Drug: Metronidazole cream
Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser
Drug: Metronidazole Emulsion
Metronidazole Emulsion 0.75%
Drug: Metronidazole Lotion
Metronidazole Lotion 0,75%
Drug: Brimonidine Tartrate Gel
Brimonidine Tartrate Gel 0.33%
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- 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)
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston | Massachusetts | United States |
Sponsors and Collaborators
- LEO Pharma
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18575