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

Completed

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

• Registration Number: NCT03193372
• Lead Sponsor: LEO Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Study Start: 2017-07-20
• Primary Completion: 2017-08-08
• Study Completion: 2017-11-15
• Status Verified: 2018-10
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rosacea Concierge Program	Azelaic Acid (Finacea Foam, BAY39-6251)	Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam

Primary Outcome Measures

Name	Time	Method
Demographics and clinical characteristics	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	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	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
Past use of topical rosacea treatments	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	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)	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)	one-time survey in 2 week recruitment window	DLQI is a widely used dermatology-related quality of life tool

Trial Locations

Locations (1)

Xcenda, LLC; 🇺🇸 Palm Harbor, Florida, United States