RosaceaNCT03193372
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
An observational study of Rosacea, run by LEO Pharma at 1 site in United States.
Trial summary
To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Azelaic Acid (Finacea Foam, BAY39-6251)
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 15 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam
Who may be able to join
- 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
Who cannot join
- Use of any other topical treatment for rosacea at the time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment
- Conditions
- Rosacea
- Being tested
- Azelaic Acid (Finacea Foam, BAY39-6251)
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic Acid (Finacea Foam, BAY39-6251)Drug
Finacea Foam, Active substance Azelaic acid
| Study group | Role | What they receive |
|---|---|---|
| Rosacea Concierge Program | Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam Receives: Drug: Azelaic Acid (Finacea Foam, BAY39-6251) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and clinical characteristics
Collected patient demographics and characteristics are :
- Year of birth
- Gender
- Insurance type
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one-time survey in 2 week recruitment window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Jul 2017
- Primary completion8 Aug 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193372
- Sponsor's protocol ID
- 19638
- Status last verified
- Oct 2018
- First submitted
- 19 Jun 2017
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea
- ClinicalTrials.gov ID
- NCT03193372
- Acronym / sponsor ID
- 19638
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their Finacea Foam treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosacea Concierge Program | – | Drug: Azelaic Acid (Finacea Foam, BAY39-6251)Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with rosacea and currently receiving topical monotherapy with Finacea Foam
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Use of any other topical treatment for rosacea at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azelaic Acid (Finacea Foam, BAY39-6251)Finacea Foam, Active substance Azelaic acid | Drug | Rosacea Concierge Program |
Primary outcome
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) * Unknown
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by LEO Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics and clinical characteristics (time frame: one-time survey in 2 week recruitment window). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.