Clinical trial NCT02602470: Preferences & Treatment Satisfaction Drivers in Rosacea Patients
Official title: A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2015-11-11
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are using topical rosacea treatment

Brief summary: To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.


Eligibility 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

Primary outcomes:
measure: Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments
timeFrame: Rosacea treatment in the past 4 weeks
Secondary outcomes:
measure: Self-reported likelihood of switching to a topical rosacea treatments
timeFrame: Rosacea treatment in the past 4 weeks
measure: Quality of life
timeFrame: Rosacea treatment in the past 4 weeks
measure: Treatment satisfaction
timeFrame: Rosacea treatment in the past 4 weeks
measure: Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment
timeFrame: Rosacea treatment in the past 4 weeks
Other outcomes:
measure: Baseline demographics and clinical characteristics: Age
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Baseline demographics and clinical characteristics: Gender
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Baseline demographics and clinical characteristics: Insurance type
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Baseline demographics and clinical characteristics: Charlson Comorbidity Index (CCI)
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Baseline demographics and clinical characteristics: Rosacea-relevant comorbidities and complications
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Baseline demographics and clinical characteristics: Rosacea treatment-related adverse events
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Current and past medication use
timeFrame: Retrospective database analysis: encompassing patient data from up to 5 years
measure: Self-reported adverse events associated with patients' satisfaction/dissatisfaction
timeFrame: Rosacea treatment in the past 4 weeks
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: