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Preferences & Treatment Satisfaction Drivers in Rosacea Patients

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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

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

Condition or disease Intervention/treatment
Rosacea 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

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea
Actual Study Start Date : January 8, 2015
Actual Primary Completion Date : March 10, 2016
Actual Study Completion Date : March 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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%




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are using topical rosacea treatment
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602470


Locations
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United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02602470     History of Changes
Other Study ID Numbers: 18575
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Metronidazole
Brimonidine Tartrate
Azelaic acid
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Dermatologic Agents