MigraineNCT03872050
Deep Phenotyping of Rosacea and Migraine
An observational study of Migraine and Rosacea, run by Danish Headache Center at 1 site in Denmark.
Trial summary
This study aims to deep phenotype patients with rosacea and migraine Read more about this study
- Who is it for?
- Ages 18 to 80 years
- How many people
- 613 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Sep 2018to 29 Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rosacea * patients invited to participate through 3 different clinics in Copenhagen and Zealand, Denmark Migraine * patients attending the outpatient clinic of the Danish Headache Center invited to participate
Who may be able to join
- diagnosis with either rosacea and/or migraine
Who cannot join
- does not want to participate
- cannot co-operate to investigation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to deep phenotype patients with rosacea and migraine
Read the detailed description
Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated.
The purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.
- Being tested
- No intervention apart from tests, including interview
- Medical subject headings
- Migraine Disorders, Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention apart from tests, including interviewDiagnostic test
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Rosacea | Patients who have been diagnosed with rosacea Receives: Diagnostic Test: No intervention apart from tests, including interview | |
| Migraine | Patients who have been diagnosed with migraine Receives: Diagnostic Test: No intervention apart from tests, including interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of migraine in rosacea cohort
Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine
Measured: 60 minutes
Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort
Prevalence of patients in migraine cohort who fulfill diagnostic criteria for rosacea
Measured: 60 minutes
Secondary outcomes (2)
Prevalence of migraine subtypes in rosacea cohort
Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for subtypes of migraine according to international headache society classification
Measured: 60 minutes
Prevalence of rosacea subtypes in migraine cohort
Prevalence of patients in migraine cohort who fulfill diagnostic criteria for subtypes of rosacea
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start14 Sep 2018
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nita Katarina Frifelt Wienholtz, Danish Headache Center
- Investigators
- Messoud Ashina, MD, PhD, DMSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872050
- Sponsor's protocol ID
- RosMigInterview
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wienholtz NKF, Christensen CE, Ashina H, Jorgensen NR, Egeberg A, Thyssen JP, Ashina M. Elevated plasma levels of calcitonin gene-related peptide in individuals with rosacea: A cross-sectional case-control study. J Eur Acad Dermatol Venereol. 2025 Jan;39(1):181-188. doi: 10.1111/jdv.19954. Epub 2024 Apr 1.
PubMed 38558478Wienholtz NKF, Christensen CE, Haugaard JH, Zhang DG, Ashina M, Thyssen JP, Egeberg A. Cohort profile: COpenhagen ROsacea COhort (COROCO) and COpenhagen MIgraine COhort (COMICO). BMJ Open. 2020 Aug 20;10(8):e039445. doi: 10.1136/bmjopen-2020-039445.
PubMed 32819957
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Phenotyping of Rosacea and Migraine
- ClinicalTrials.gov ID
- NCT03872050
- Acronym / sponsor ID
- RosMigInterview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 12 Mar 2019 (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.
This study aims to deep phenotype patients with rosacea and migraine
Detailed description
Rosacea and migraine are common disorders that overlap in epidemiology, symptoms, trigger factors, and distribution in the trigeminal area. Recent studies establish a connection between the two disorders, which needs to be investigated.
The purpose of this study is investigate the link between the two disorders by deep phenotyping through semi-structured interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosacea | – | Diagnostic Test: No intervention apart from tests, including interviewPatients who have been diagnosed with rosacea |
| Migraine | – | Diagnostic Test: No intervention apart from tests, including interviewPatients who have been diagnosed with migraine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rosacea * patients invited to participate through 3 different clinics in Copenhagen and Zealand, Denmark Migraine * patients attending the outpatient clinic of the Danish Headache Center invited to participate
Key inclusion criteria (1 listed)
- diagnosis with either rosacea and/or migraine
Key exclusion criteria (2 listed)
- does not want to participate
- cannot co-operate to investigation
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 |
|---|---|---|
| No intervention apart from tests, including interviewNo interventions | Diagnostic test | Migraine, Rosacea |
Primary outcome
Prevalence of migraine in rosacea cohort
Time frame: 60 minutes
Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine
Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort
Time frame: 60 minutes
Prevalence of patients in migraine cohort who fulfill diagnostic criteria for rosacea
2 secondary outcomes
Prevalence of migraine subtypes in rosacea cohort
Time frame: 60 minutes
Prevalence of rosacea subtypes in migraine cohort
Time frame: 60 minutes
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 12 Aug 2020.
- Derived from this study: PubMed 38558478Wienholtz NKF, Christensen CE, Ashina H, Jorgensen NR, Egeberg A, Thyssen JP, Ashina M. Elevated plasma levels of calcitonin gene-related peptide in individuals with rosacea: A cross-sectional case-control study. J Eur Acad Dermatol Venereol. 2025 Jan;39(1):181-188. doi: 10.1111/jdv.19954. Epub 2024 Apr 1.
- Derived from this study: PubMed 32819957Wienholtz NKF, Christensen CE, Haugaard JH, Zhang DG, Ashina M, Thyssen JP, Egeberg A. Cohort profile: COpenhagen ROsacea COhort (COROCO) and COpenhagen MIgraine COhort (COMICO). BMJ Open. 2020 Aug 20;10(8):e039445. doi: 10.1136/bmjopen-2020-039445.
- 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.
Messoud Ashina, MD, PhD, DMSc principal investigator
Professor
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 Migraine and Rosacea, run by Danish Headache Center at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 12 Aug 2020. 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 Denmark. 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?
Prevalence of migraine in rosacea cohort (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872050, which also lists 2 linked publications.
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 12 Aug 2020.