RosaceaNCT02602470
Preferences & Treatment Satisfaction Drivers in Rosacea Patients
An observational study of Rosacea, run by LEO Pharma at 1 site in United States.
Trial summary
To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction. 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 Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251), Azelaic Acid Cream and Metronidazole gel
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2015to 10 Mar 2016
- 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 who are using topical rosacea treatment
Who may be able to join
- Male or female patients of at least 18 years of age at index date
- At least one prescription for a topical rosacea treatments: Azelaic Acid Gel, Azelaic Acid Cream, Metronidazole Gel, Metronidazole Cream, Metronidazole Emulsion, Metronidazole Lotion, Brimonidine Tartrate Gel
- At least one medical record with a diagnosis code for rosacea (ICD-9: 695.3)
- At least 6 months of data history prior to the index date
- Had at least one encounter at the Reliant Medical Group within 3 months prior to 01 January 2015
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea
To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
- Conditions
- Rosacea
- Being tested
- Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251), Azelaic Acid Cream, Metronidazole gel, Metronidazole cream, Metronidazole Emulsion
- 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 Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)Drug
Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser \& Moisturizing
Azelaic Acid CreamDrug
Azelaic Acid Cream 20%
Metronidazole gelDrug
Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser
Metronidazole creamDrug
Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser
Metronidazole EmulsionDrug
Metronidazole Emulsion 0.75%
Metronidazole LotionDrug
Metronidazole Lotion 0,75%
Brimonidine Tartrate GelDrug
Brimonidine Tartrate Gel 0.33%
| Study group | Role | What they receive |
|---|---|---|
| Rosacea treated patients | Patients using topical rosacea treatment Receives: Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251); Drug: Azelaic Acid Cream; Drug: Metronidazole gel; Drug: Metronidazole cream; Drug: Metronidazole Emulsion; Drug: Metronidazole Lotion; Drug: Brimonidine Tartrate Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments
Assessed from the Rosacea Treatment Preference Questionnaire:
Rated on a scale of 0 to 10, with 0 meaning not at all important and 10 meaning extremely important
Measured: Rosacea treatment in the past 4 weeks
Secondary outcomes (4)
Self-reported likelihood of switching to a topical rosacea treatments
Assessed from the Rosacea Treatment Preference Questionnaire:
Rated on a scale of 0 to 10, with 0 meaning not at all likely and 10 meaning extremely likely
Measured: Rosacea treatment in the past 4 weeks
Quality of life
Measured using Dermatology Life Quality Index (DLQI):
The DLQI consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, and school, personal relationships and treatment
Measured: Rosacea treatment in the past 4 weeks
Treatment satisfaction
Assessed by a score on the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). Scores will be standardized and expressed as a 0-100 standardized score
Measured: Rosacea treatment in the past 4 weeks
Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment
Extracted from the Rosacea Treatment Preference Questionnaire
Measured: Rosacea treatment in the past 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start8 Jan 2015
- Primary completion10 Mar 2016
- Study completion10 Mar 2016
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
- Cross-sectional
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602470
- Sponsor's protocol ID
- 18575
- Status last verified
- Apr 2017
- First submitted
- 10 Nov 2015
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea
- ClinicalTrials.gov ID
- NCT02602470
- Acronym / sponsor ID
- 18575
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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 patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosacea treated patients | – | Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251), Drug: Azelaic Acid Cream, Drug: Metronidazole gel, Drug: Metronidazole cream, Drug: Metronidazole Emulsion, Drug: Metronidazole Lotion, Drug: Brimonidine Tartrate GelPatients using topical rosacea treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are using topical rosacea treatment
Key inclusion criteria (5 listed)
- Male or female patients of at least 18 years of age at index date
- At least one prescription for a topical rosacea treatments: Azelaic Acid Gel, Azelaic Acid Cream, Metronidazole Gel, Metronidazole Cream, Metronidazole Emulsion, Metronidazole Lotion, Brimonidine Tartrate Gel
- At least one medical record with a diagnosis code for rosacea (ICD-9: 695.3)
- At least 6 months of data history prior to the index date
- Had at least one encounter at the Reliant Medical Group within 3 months prior to 01 January 2015
Key exclusion criteria (1 listed)
- None
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 Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser \& Moisturizing | Drug | Rosacea treated patients |
| Azelaic Acid CreamAzelaic Acid Cream 20% | Drug | Rosacea treated patients |
| Metronidazole gelMetronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser | Drug | Rosacea treated patients |
| Metronidazole creamMetronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser | Drug | Rosacea treated patients |
| Metronidazole EmulsionMetronidazole Emulsion 0.75% | Drug | Rosacea treated patients |
| Metronidazole LotionMetronidazole Lotion 0,75% | Drug | Rosacea treated patients |
| Brimonidine Tartrate GelBrimonidine Tartrate Gel 0.33% | Drug | Rosacea treated patients |
Primary outcome
Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments
Time frame: Rosacea treatment in the past 4 weeks
Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning not at all important and 10 meaning extremely important
4 secondary outcomes
Self-reported likelihood of switching to a topical rosacea treatments
Time frame: Rosacea treatment in the past 4 weeks
Quality of life
Time frame: Rosacea treatment in the past 4 weeks
Treatment satisfaction
Time frame: Rosacea treatment in the past 4 weeks
Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment
Time frame: Rosacea treatment in the past 4 weeks
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.
Bayer Study Director study director
Bayer
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 5 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?
Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments (time frame: Rosacea treatment in the past 4 weeks). 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.