Deep Phenotyping of Rosacea and Migraine

August 11, 2020 updated by: Nita Katarina Frifelt Wienholtz, Danish Headache Center
This study aims to deep phenotype patients with rosacea and migraine

Study Overview

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 Type

Observational

Enrollment (Actual)

613

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zealand
      • Glostrup, Zealand, Denmark, DK-2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • diagnosis with either rosacea and/or migraine

Exclusion Criteria:

  • does not want to participate
  • cannot co-operate to investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rosacea
Patients who have been diagnosed with rosacea
No interventions
Migraine
Patients who have been diagnosed with migraine
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of migraine in rosacea cohort
Time Frame: 60 minutes
Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine
60 minutes
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
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of migraine subtypes in rosacea cohort
Time Frame: 60 minutes
Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for subtypes of migraine according to international headache society classification
60 minutes
Prevalence of rosacea subtypes in migraine cohort
Time Frame: 60 minutes
Prevalence of patients in migraine cohort who fulfill diagnostic criteria for subtypes of rosacea
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Messoud Ashina, MD, PhD, DMSc, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Actual)

October 29, 2019

Study Completion (Actual)

October 29, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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