Deep Phenotyping of Rosacea and Migraine

• Sponsor: Danish Headache Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03872050
• Collaborator: (none)
• Enrollment: 613
• Location: 1
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 45.5

Study Details

Study Description

Brief Summary

This study aims to deep phenotype patients with rosacea and migraine

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 613 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Deep Phenotyping of Rosacea and Migraine
• Actual Study Start Date: Sep 14, 2018
• Actual Primary Completion Date: Oct 29, 2019
• Actual Study Completion Date: Oct 29, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Prevalence of migraine in rosacea cohort [60 minutes]

   Prevalence of patients in rosacea cohort who fulfill diagnostic criteria for migraine

2. Prevalence of rosacea in migraine cohort Prevalence of rosacea in migraine cohort [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 [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 [60 minutes]

   Prevalence of patients in migraine cohort who fulfill diagnostic criteria for subtypes of rosacea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis with either rosacea and/or migraine

Exclusion Criteria:

• does not want to participate

• cannot co-operate to investigation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danish Headache Center	Glostrup	Zealand	Denmark	DK-2600

Sponsors and Collaborators

• Danish Headache Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Fellow, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT03872050
• Other Study ID Numbers: RosMigInterview
• First Posted: Mar 12, 2019
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Migraine Disorders; Rosacea

Study Results

No Results Posted as of Aug 12, 2020