Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193372
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Rosacea Drug: Azelaic Acid (Finacea Foam, BAY39-6251)

Layout table for study information
Study Type : Observational
Actual Enrollment : 2200 participants
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
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Group/Cohort Intervention/treatment
Rosacea Concierge Program
Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam
Drug: Azelaic Acid (Finacea Foam, BAY39-6251)
Finacea Foam, Active substance Azelaic acid




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam
Criteria

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


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): NCT03193372


Locations
Layout table for location information
United States, Florida
Xcenda, LLC
Palm Harbor, Florida, United States, 34685
Sponsors and Collaborators
Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03193372     History of Changes
Other Study ID Numbers: 19638
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents