RosaceaNCT02292836
Rosacea Prevalence in General Population - Pilot Study
An observational study of Rosacea, run by Galderma R&D at 2 sites in 2 countries.
Trial summary
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Questionnaire testing
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2012to Feb 2013
- 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: Rosacea and non-rosacea patients
- Male or Female aged between 18 (or locally accepted majority) and 65 years old both included.
- Subject visiting one of the study dermatology practices for daily care/routine dermatology consultation.
- Subject have to read and sign the approved Informed Consent form prior to any participation in the study,
- Subject willing and capable of cooperating to the extend and degree required by the protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.
Read the detailed description
The study will test the subject questionnaire aimed to be used in a full general population prevalence study to screen potential subjects with rosacea.
Questionnaire will be self-administrated to Dermatology outpatients.
Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.
- Conditions
- Rosacea
- Being tested
- Questionnaire testing
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire testingOther
Questionnaire testing on rosacea and non-rosacea dermatology outpatients
| Study group | Role | What they receive |
|---|---|---|
| rosacea patients | Questionnaire testing on routine dermatologist patient population Receives: Other: Questionnaire testing | |
| non-rosacea patients | Questionnaire testing on routine dermatologist patient population Receives: Other: Questionnaire testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of questions
sensitivity and specificity of each questionnaire key items by comparing subject answers and investigator assessments, as follows: Sensitivity= True Positive/(True Positive+False Negative)
Specificity= True Negative/ (False Positive+True Negative)
Measured: Day 1
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 startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- 120 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
- NCT02292836
- Sponsor's protocol ID
- RD.03.SPR.29105
- 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
- Rosacea Prevalence in General Population - Pilot Study
- ClinicalTrials.gov ID
- NCT02292836
- Acronym / sponsor ID
- RD.03.SPR.29105
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (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.
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.
Detailed description
The study will test the subject questionnaire aimed to be used in a full general population prevalence study to screen potential subjects with rosacea.
Questionnaire will be self-administrated to Dermatology outpatients.
Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rosacea patients | – | Other: Questionnaire testingQuestionnaire testing on routine dermatologist patient population |
| non-rosacea patients | – | Other: Questionnaire testingQuestionnaire testing on routine dermatologist patient population |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rosacea and non-rosacea patients
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 |
|---|---|---|
| Questionnaire testingQuestionnaire testing on rosacea and non-rosacea dermatology outpatients | Other | non-rosacea patients, rosacea patients |
Primary outcome
sensitivity and specificity of questions
Time frame: Day 1
sensitivity and specificity of each questionnaire key items by comparing subject answers and investigator assessments, as follows: Sensitivity= True Positive/(True Positive+False Negative) Specificity= True Negative/ (False Positive+True Negative)
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by Galderma R&D at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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.
Where is the study taking place?
The record lists 2 sites in Canada, Sweden. 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?
sensitivity and specificity of questions (time frame: Day 1). 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.