RosaceaNCT03228927
Characterization of the Facial and Gut Microbiome in Rosacea
An observational study of Rosacea, run by The Acne Cure Alliance.
Trial summary
Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rosacea
- What is being tested?
- comparison of twin A to twin B
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2017to 6 Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea
Who may be able to join
- Presenting with monozygotic or dizygotic twin
- One or both twins with facial rosacea
- Willingness to allow facial and fecal samples to be analyzed -
Who cannot join
- Non-twin siblings
- Absence of facial rosacea in both twins -
About this study
Official title: Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.
Read the detailed description
- Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
- Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
- Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
- Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.
- Conditions
- Rosacea
- Being tested
- comparison of twin A to twin B
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of twin A to twin BOther
Comparison of Twin A to Twin B
| Study group | Role | What they receive |
|---|---|---|
| twin A | Sampling of the facial and fecal microbiome Receives: Other: comparison of twin A to twin B | |
| twin B | Sampling of the facial and fecal microbiome Receives: Other: comparison of twin A to twin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls
Measured: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start5 Aug 2017 (estimated)
- Primary completion6 Aug 2017 (estimated)
- Study completion6 Aug 2017 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Acne Cure Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilary Baldwin, The Acne Cure Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228927
- Sponsor's protocol ID
- 713
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
- ClinicalTrials.gov ID
- NCT03228927
- Acronym / sponsor ID
- 713
- Conditions
- Rosacea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Acne Cure AllianceUniversity, hospital or other
- Study start
- 5 Aug 2017 (estimated)
- Primary completion
- 6 Aug 2017 (estimated)
- Study completion
- 6 Aug 2017 (estimated)
- First posted
- 25 Jul 2017 (actual)
- 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.
Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.
Detailed description
- Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
- Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
- Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
- Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| twin A | – | Other: comparison of twin A to twin BSampling of the facial and fecal microbiome |
| twin B | – | Other: comparison of twin A to twin BSampling of the facial and fecal microbiome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea
Key inclusion criteria (3 listed)
- Presenting with monozygotic or dizygotic twin
- One or both twins with facial rosacea
- Willingness to allow facial and fecal samples to be analyzed -
Key exclusion criteria (2 listed)
- Non-twin siblings
- Absence of facial rosacea in both twins -
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 |
|---|---|---|
| comparison of twin A to twin BComparison of Twin A to Twin B | Other | twin A, twin B |
Primary outcome
Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
Time frame: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.
Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: No. There is no plan to share any IPD with other researchers
Related trials for Rosacea
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rosacea, run by The Acne Cure Alliance.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Jul 2017. 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?
Results are not available in the source record.
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?
Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea (time frame: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.). 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 Jul 2017.