Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preferences & Treatment Satisfaction Drivers in Rosacea Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02602470
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date November 10, 2015
First Posted Date November 11, 2015
Last Update Posted Date May 11, 2017
Actual Study Start Date January 8, 2015
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2017)
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
Original Primary Outcome Measures
 (submitted: November 10, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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
Change History Complete list of historical versions of study NCT02602470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 10, 2017)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: November 10, 2015)
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Preferences & Treatment Satisfaction Drivers in Rosacea Patients
Official Title A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea
Brief Summary To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who are using topical rosacea treatment
Condition 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
  • 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%
Study Groups/Cohorts Rosacea treated patients
Patients using topical rosacea treatment
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 18, 2016)
206
Original Estimated Enrollment
 (submitted: November 10, 2015)
800
Actual Study Completion Date March 10, 2016
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
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:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02602470
Other Study ID Numbers 18575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2017