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

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Azelaic Acid (Finacea Foam, BAY39-6251)

• Study Type: Observational
• Enrollment (Actual): 2200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Palm Harbor, Florida, United States, 34685
      • Xcenda, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics and clinical characteristics	Collected patient demographics and characteristics are : Year of birth; Gender; Insurance type	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	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	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	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	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	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	one-time survey in 2 week recruitment window

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ACTUAL): August 8, 2017
• Study Completion (ACTUAL): November 15, 2017

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (ACTUAL): June 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 19638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No