Preferences & Treatment Satisfaction Drivers in Rosacea Patients

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

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

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251); Drug: Azelaic Acid Cream; Drug: Metronidazole gel; Drug: Metronidazole cream; Drug: Metronidazole Emulsion; Drug: Metronidazole Lotion; Drug: Brimonidine Tartrate Gel

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are using topical rosacea treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2015
• Primary Completion (Actual): March 10, 2016
• Study Completion (Actual): March 10, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Anti-Infective Agents; Antineoplastic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Brimonidine Tartrate; Metronidazole; Azelaic acid
• Other Study ID Numbers: 18575