check_circleStudy Completed

Rosacea

Bayer Identifier:

18575

ClinicalTrials.gov Identifier:

NCT02602470

EudraCT Number:

Not Available

EU CT Number:

Not Available
Preferences & Treatment Satisfaction Drivers in Rosacea Patients

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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


  • - None

Trial summary

Enrollment Goal
206
Trial Dates
January 2015 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Boston, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    Rosacea treatment in the past 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Rosacea treatment in the past 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Rosacea treatment in the past 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Rosacea treatment in the past 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Rosacea treatment in the past 4 weeks

Trial design

A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients with Rosacea
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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