check_circleStudy Completed

Rosacea

Bayer Identifier:

19638

ClinicalTrials.gov Identifier:

NCT03193372

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated with Finacea Foam for Rosacea

Trial purpose

To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - At least 18 years of age
    - Diagnosis of rosacea by a medical professional
    - Currently using Finacea Foam as topical monotherapy for rosacea
    - Willing and able to provide voluntary, informed consent to participate in this study
  • - Use of any other topical treatment for rosacea at the time of enrollment

Trial summary

Enrollment Goal
2200
Trial Dates
July 2017 - November 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Xcenda, LLCPalm Harbor, 34685, United States

Primary Outcome

  • Demographics and clinical characteristics
    Collected patient demographics and characteristics are : -Year of birth - Gender - Insurance type
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Rosacea-relevant comorbidities and complications
    Patient reported history of the following will be collected : - Blepharitis - Conjunctivitis - Corneal neovascularization/keratitis - Depression - Migraine
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Rosacea subtype
    Patient reported diagnosis of the following will be collected: - Erythematotelangiectatic (facial redness) - Papulopustular (bumps and pimples) - Phymatous (enlargement of the nose) - Ocular (eye irritation) - Unknown
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Past use of topical rosacea treatments
    Patient reported use of the following medications will be collected: - Metronidazole gel - Metronidazole cream - Metronidazole lotion - Metronidazole emulsion - Brimonidine tartrate gel
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Patient concerns collected by Rosacea Treatment Preference Questionnaire
    Rosacea Treatment Preference Questionnaire is a survey to assess patient self-reported rosacea subtype and severity, and to evaluate the concerns that contribute to patient satisfaction/dissatisfaction, as well as treatment decisions with rosacea topical treatments
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Treatment satisfaction assessed by Satisfaction with Medicines Questionnaire (SATMED-Q)
    SATMED-Q is a 17-question, validated, multidimensional generic questionnaire designed for use in patients with any chronic disease treated with medicines
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window
  • Quality of life measured by Dermatology Life Quality Index (DLQI)
    DLQI is a widely used dermatology-related quality of life tool
    date_rangeTime Frame:
    one-time survey in 2 week recruitment window

Trial design

A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated with Finacea Foam for 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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