RosaceaNCT02749786
Genetic Basis of Rosacea Study (Control)
A study testing Skin Biopsy in people with 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. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. 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?
- Skin Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2016to 1 Aug 2016
- Phase
- Interventional
- 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
Who may be able to join
- Fitzpatrick skin type II or III
- Age greater than or equal to 18 years
- Individuals without a history of rosacea
Who cannot join
- 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: Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls
Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes 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
- Skin Biopsy
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin BiopsyOther
Skin biopsies will be performed via the Keys punch technique from normal facial skin.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Participants who do not have rosacea (control group) Receives: Other: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.
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 posted25 Apr 2016 (estimated)
- Study start21 Jan 2016
- Primary completion1 Aug 2016
- Study completion1 Aug 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Chang, Stanford University
- Investigators
- Anne Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749786
- Sponsor's protocol ID
- 22419
- Status last verified
- Sep 2019
- First submitted
- 18 Apr 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls
- ClinicalTrials.gov ID
- NCT02749786
- Acronym / sponsor ID
- 22419
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 25 Apr 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. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Skin BiopsyParticipants who do not have rosacea (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fitzpatrick skin type II or III
- Age greater than or equal to 18 years
- Individuals without a history of rosacea
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Skin BiopsySkin biopsies will be performed via the Keys punch technique from normal facial skin. | Other | Control Group |
Primary outcome
Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.
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.
- Individual participant dataSharing planned: No
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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.
Anne Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Biopsy in people with 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 3 inclusion and 3 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?
Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea. (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; AzTrials last refreshed its copy on 30 Oct 2026.