Skip to main content
OpenTrials
Completed

NCT Number: NCT02602470

Preferences & Treatment Satisfaction Drivers in Rosacea Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)

Drug

Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing

Azelaic Acid Cream

Drug

Azelaic Acid Cream 20%

Metronidazole gel

Drug

Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser

Metronidazole cream

Drug

Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser

Metronidazole Emulsion

Drug

Metronidazole Emulsion 0.75%

Metronidazole Lotion

Drug

Metronidazole Lotion 0,75%

Brimonidine Tartrate Gel

Drug

Brimonidine Tartrate Gel 0.33%

Primary outcomes

  1. Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments

    Time frame: 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 outcomes

  1. Self-reported likelihood of switching to a topical rosacea treatments

    Time frame: 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

  2. Quality of life

    Time frame: 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

  3. Treatment satisfaction

    Time frame: 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

  4. Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment

    Time frame: Rosacea treatment in the past 4 weeks

    Extracted from the Rosacea Treatment Preference Questionnaire

Other outcomes

  1. Baseline demographics and clinical characteristics: Age

    Time frame: Retrospective database analysis: encompassing patient data from up to 5 years

    Assessed from retrospective analysis of electronic medical records

  2. Baseline demographics and clinical characteristics: Gender

    Time frame: Retrospective database analysis: encompassing patient data from up to 5 years

    Assessed from retrospective analysis of electronic medical records

  3. Baseline demographics and clinical characteristics: Insurance type

    Time frame: Retrospective database analysis: encompassing patient data from up to 5 years

    Assessed from retrospective analysis of electronic medical records

  4. Baseline demographics and clinical characteristics: Charlson Comorbidity Index (CCI)

    Time frame: Retrospective database analysis: encompassing patient data from up to 5 years

    Assessed from retrospective analysis of electronic medical records

  5. Baseline demographics and clinical characteristics: Rosacea-relevant comorbidities and complications

    Time frame: 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)

  6. Baseline demographics and clinical characteristics: Rosacea treatment-related adverse events

    Time frame: 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)

  7. Current and past medication use

    Time frame: 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

  8. Self-reported adverse events associated with patients' satisfaction/dissatisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.