RosaceaRISENCT02292797
Assessment of the Rosacea Prevalence in the General Population
An observational study of Rosacea, run by Galderma R&D.
Trial summary
Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Prevalence assessment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Part I: Subjects will be screened from the general population by questionnaires mainly focusing on detection of signs and symptoms of rosacea. Subjects' answers will be submitted to a pre-defined algorithm to identify the potential subjects with rosacea (screened positive for rosacea, Screened R+). Part II: A subgroup of subjects (100 maximum per country) will be randomly selected among those who screened positive for rosacea and will be referred to the closest investigational site (dermatologist practice).
Who may be able to join
- The following subjects will be included in the study:
- Subjects aged 18 to 65 years old from the general population
- Subjects who are willing to complete the questionnaires
- Part II
- The following subjects will be included in Part II of the study:
- Subjects who screened positive for rosacea during the first part of the study and selected by random method
- Subjects who gave their informed consent to participate in Part II of the study
Who cannot join
None listed.
About this study
Official title: Assessment of the Prevalence of Rosacea in the General Population
Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population.
Read the detailed description
Primary objective:
Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis
- Conditions
- Rosacea
- Being tested
- Prevalence assessment
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence assessmentOther
Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of subjects with rosacea diagnosis confirmed
estimation of the percentage of rosacea patients in the general population
Measured: general population will be surveyed over an expected average duration of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabien AUDIBERT, Bsc, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292797
- Sponsor's protocol ID
- RD.03.SPR.29104
- Acronym
- RISE
- Status last verified
- Nov 2014
- First submitted
- 14 Oct 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Rosacea in the General Population
- ClinicalTrials.gov ID
- NCT02292797
- Acronym / sponsor ID
- RISE / RD.03.SPR.29104
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Nov 2014 (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.
Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population.
Detailed description
Primary objective:
Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Part I: Subjects will be screened from the general population by questionnaires mainly focusing on detection of signs and symptoms of rosacea. Subjects' answers will be submitted to a pre-defined algorithm to identify the potential subjects with rosacea (screened positive for rosacea, Screened R+). Part II: A subgroup of subjects (100 maximum per country) will be randomly selected among those who screened positive for rosacea and will be referred to the closest investigational site (dermatologist practice).
Key inclusion criteria (7 listed)
- Subjects aged 18 to 65 years old from the general population
- Subjects who are willing to complete the questionnaires
- Part II
- Subjects who screened positive for rosacea during the first part of the study and selected by random method
- Subjects who gave their informed consent to participate in Part II of the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prevalence assessmentAssessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis | Other | – |
Primary outcome
percentage of subjects with rosacea diagnosis confirmed
Time frame: general population will be surveyed over an expected average duration of 6 months
estimation of the percentage of rosacea patients in the general population
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 17 Nov 2014.
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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.
Fabien AUDIBERT, Bsc study director
Galderma R&D
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by Galderma R&D.
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 7 inclusion and 0 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 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
percentage of subjects with rosacea diagnosis confirmed (time frame: general population will be surveyed over an expected average duration of 6 months). 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 17 Nov 2014.