Preferences & Treatment Satisfaction Drivers in Rosacea Patients

Rosacea Clinical Trial

Official title:

A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602470
• Other study ID #: 18575
• Status: Completed
• Start date: January 8, 2015
• Est. completion date: March 10, 2016

Study information

• Verified date: April 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 10, 2016
• Est. primary completion date: March 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)
Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing
• Azelaic Acid Cream
Azelaic Acid Cream 20%
• Metronidazole gel
Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser
• Metronidazole cream
Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser
• Metronidazole Emulsion
Metronidazole Emulsion 0.75%
• Metronidazole Lotion
Metronidazole Lotion 0,75%
• Brimonidine Tartrate Gel
Brimonidine Tartrate Gel 0.33%

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Baseline demographics and clinical characteristics: Gender	Assessed from retrospective analysis of electronic medical records	Retrospective database analysis: encompassing patient data from up to 5 years
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Quality of life	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
Secondary	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
Secondary	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