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NCT03989492 Clinical Trial

Role of the Sympathetic Nervous System in Rosacea

Rosacea Clinical Trial

Official title:
Role of the Sympathetic Nervous System in Rosacea

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03989492
Other study ID # 1R15AR069912-01A1
Secondary ID 1R15AR069912-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date May 24, 2019
Est. completion date August 2024

Study information
Verified date October 2023
Source Indiana University
Contact Kristen Metzler-Wilson, PT, PhD
Phone 317-278-1871
Email dptlab@iupui.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects. Exclusion Criteria: - Neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders - Current history of alcohol and/or drug abuse - Known allergies or hypersensitivities to medications/drugs that are used in the protocol - Current smoking or regular smoking within the last 2 years - Body mass index > 35 kg/m2 - Medications or supplements which are known to affect neural, cardiovascular, or muscular responses

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• systemic and local stressors
Protocol 1: skin sympathetic nerve activity will be measured during mental math and handgrip exercise. Protocol 2: skin end organ responses will be measured at baseline and in response to systemic stressors and end-organ receptor stimulation. Protocol 3: skin end organ responses will be measured at baseline and during local heating.

Locations
Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (3)
Lead Sponsor Collaborator
Indiana University Marian University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin blood flow laser Doppler flowmetry Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.
Primary Skin sympathetic nerve activity microneurography Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.
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