RosaceaNCT02787616
Genetic Basis of Rosacea
An observational study of Rosacea, run by Stanford University at 1 site in United States.
Trial summary
Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well understood and current methods to treat this disease are often unsatisfactory. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- buccal swab
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2012to 16 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 300 individuals will be enrolled, 150 with dermatologist verified rosacea and 150 without rosacea.
Who may be able to join
- Clinical signs and symptoms of rosacea (papulopustular or erythrotelangiectatic subtypes) present at enrollment as determined by the investigator
- All four grandparents of European descent
- Fitzpatrick skin type I or II
- Age 18 years or older
- No history of rosacea
- No clinical signs or symptoms of rosacea
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- No family history of rosacea
- All four grandparents of European descent
- Fitzpatrick skin type I or II
- Age 18 years or older
Who cannot join
- Unable or unwilling to provide written informed consent
- Concomitant facial or medical condition that obscures diagnosis of rosacea (such as malar erythema from lupus erythematosus)
- Acne vulgaris
- Unable or unwilling to provide peripheral blood sample (a few teaspoons)
- Inability for investigator to verify rosacea diagnosis on clinical examination due to rosacea treatment(s) leading to complete lack of signs and symptoms (such prior laser treatments, systemic tetracycline usage, etc.)
- Use of topical prescription medications or procedures to the face within one month of enrollment
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- Women who are pregnant or lactating
- Eligibility Criteria for Non-Rosacea Group:
- Unable or unwilling to provide written informed consent
- Acne vulgaris
- Unable or unwilling to provide peripheral blood sample (a few teaspoons)
- Women who are pregnant or lactating
- Use of topical prescription medications or procedures to the face within one month of enrollment
- Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Dermatology
Redwood City, California, 94603
About this study
Official title: Validation of Candidate Rosacea Genes By Targeted Interrogation of Alleles and Assessment of Rosacea Co-morbidities
Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well understood and current methods to treat this disease are often unsatisfactory. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigators hope to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.
- Conditions
- Rosacea
- Being tested
- buccal swab
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal swabGenetic
cheek swab for DNA sampling
| Study group | Role | What they receive |
|---|---|---|
| Rosacea Group | Not described Receives: Genetic: buccal swab | |
| Non-Rosacea Group | Not described Receives: Genetic: buccal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted interrogation of alleles and assessment of rosacea co-morbidities.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start13 Apr 2012
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
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 Stanford UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Chang, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787616
- Sponsor's protocol ID
- R15006
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Candidate Rosacea Genes By Targeted Interrogation of Alleles and Assessment of Rosacea Co-morbidities
- ClinicalTrials.gov ID
- NCT02787616
- Acronym / sponsor ID
- R15006
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 13 Apr 2012 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 1 Jun 2016 (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.
Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well understood and current methods to treat this disease are often unsatisfactory. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigators hope to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosacea Group | – | Genetic: buccal swab |
| Non-Rosacea Group | – | Genetic: buccal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 300 individuals will be enrolled, 150 with dermatologist verified rosacea and 150 without rosacea.
Key inclusion criteria (10 listed)
- Clinical signs and symptoms of rosacea (papulopustular or erythrotelangiectatic subtypes) present at enrollment as determined by the investigator
- All four grandparents of European descent
- Fitzpatrick skin type I or II
- Age 18 years or older
- No history of rosacea
Key exclusion criteria (14 listed)
- Unable or unwilling to provide written informed consent
- Concomitant facial or medical condition that obscures diagnosis of rosacea (such as malar erythema from lupus erythematosus)
- Acne vulgaris
- Unable or unwilling to provide peripheral blood sample (a few teaspoons)
- Inability for investigator to verify rosacea diagnosis on clinical examination due to rosacea treatment(s) leading to complete lack of signs and symptoms (such prior laser treatments, systemic tetracycline usage, etc.)
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 |
|---|---|---|
| buccal swabcheek swab for DNA sampling | Genetic | Non-Rosacea Group, Rosacea Group |
Primary outcome
Targeted interrogation of alleles and assessment of rosacea co-morbidities.
Time frame: Up to 2 years
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 26 Sep 2019.
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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 Stanford University 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 10 inclusion and 14 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 26 Sep 2019. 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?
Targeted interrogation of alleles and assessment of rosacea co-morbidities. (time frame: Up to 2 years). 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 26 Sep 2019.