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NCT03193372 Clinical Trial

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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03193372
Other study ID # 19638
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2017
Est. completion date November 15, 2017

Study information
Verified date October 2018
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 2200
Est. completion date November 15, 2017
Est. primary completion date August 8, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Azelaic Acid (Finacea Foam, BAY39-6251)
Finacea Foam, Active substance Azelaic acid

Locations
Country Name City State
United States Xcenda, LLC Palm Harbor Florida

Sponsors (2)
Lead Sponsor Collaborator
LEO Pharma Bayer

Country where clinical trial is conducted

United States, 

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