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


Original post, click here
This study is not yet open for participant recruitment.

See

Verified June 2017 by Bayer

Sponsor:

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT03193372

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

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

Rosacea Drug: Finacea Foam, (Azelaic Acid, BAY39-6251)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea

Primary Outcome Measures:

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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

  • 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

Estimated Enrollment: 2200
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Rosacea Concierge Program

Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

Drug: Finacea Foam, (Azelaic Acid, BAY39-6251)

Finacea Foam, Active substance Azelaic acid

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193372

Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options ‘3’ or ‘4’) (+)1-888-84 22937

Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03193372     History of Changes
Other Study ID Numbers: 19638
Study First Received: June 19, 2017
Last Updated: June 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 20, 2017