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Deep Phenotyping of Rosacea and Migraine

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ClinicalTrials.gov Identifier: NCT03872050
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nita Katarina Frifelt Wienholtz, Danish Headache Center

Brief Summary:
This study aims to deep phenotype patients with rosacea and migraine

Condition or disease Intervention/treatment
Migraine Rosacea Diagnostic Test: No intervention apart from tests, including interview

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Deep Phenotyping of Rosacea and Migraine
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rosacea
Patients who have been diagnosed with rosacea
Diagnostic Test: No intervention apart from tests, including interview
No interventions

Migraine
Patients who have been diagnosed with migraine
Diagnostic Test: No intervention apart from tests, including interview
No interventions




Primary Outcome Measures :
  1. Prevalence of migraine in rosacea cohort [ Time Frame: 60 minutes ]
    Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine

  2. Prevalence of ri Prevalence of rosacea in migraine cohort [ Time Frame: 60 minutes ]
    Prevalence of patients in migraine cohort who fulfill diagnostic criteria for rosacea


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Mouthswab for DNA-sampling


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • diagnosis with either rosacea and/or migraine

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872050


Contacts
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Contact: Nita KF Wienholtz, MD +45 3863 4612 nwie0008@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Zealand, Denmark, DK-2600
Contact: Nita KF Wienholtz, MD    +45 3863 4612    nwie0008@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Messoud Ashina, MD, PhD, DMSc Professor

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Responsible Party: Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Fellow, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03872050     History of Changes
Other Study ID Numbers: RosMigInterview
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Migraine Disorders
Rosacea
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Skin Diseases