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OpenTrials
Completed

NCT Number: NCT03193372

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

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

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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

Xcenda, LLC

Palm Harbor, Florida, 34685, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Use of any other topical treatment for rosacea at the time of enrollment

Treatment and study plan

Azelaic Acid (Finacea Foam, BAY39-6251)

Drug

Finacea Foam, Active substance Azelaic acid

Primary outcomes

  1. Demographics and clinical characteristics

    Time frame: one-time survey in 2 week recruitment window

    Collected patient demographics and characteristics are :

    • Year of birth
    • Gender
    • Insurance type

  2. Rosacea-relevant comorbidities and complications

    Time frame: one-time survey in 2 week recruitment window

    Patient reported history of the following will be collected :

    • Blepharitis
    • Conjunctivitis
    • Corneal neovascularization/keratitis
    • Depression
    • Migraine

  3. Rosacea subtype

    Time frame: one-time survey in 2 week recruitment window

    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

  4. Past use of topical rosacea treatments

    Time frame: one-time survey in 2 week recruitment window

    Patient reported use of the following medications will be collected:

    • Metronidazole gel
    • Metronidazole cream
    • Metronidazole lotion
    • Metronidazole emulsion
    • Brimonidine tartrate gel

  5. Patient concerns collected by Rosacea Treatment Preference Questionnaire

    Time frame: one-time survey in 2 week recruitment window

    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

  6. Treatment satisfaction assessed by Satisfaction with Medicines Questionnaire (SATMED-Q)

    Time frame: one-time survey in 2 week recruitment window

    SATMED-Q is a 17-question, validated, multidimensional generic questionnaire designed for use in patients with any chronic disease treated with medicines

  7. Quality of life measured by Dermatology Life Quality Index (DLQI)

    Time frame: one-time survey in 2 week recruitment window

    DLQI is a widely used dermatology-related quality of life tool

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
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.

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