Role of the Sympathetic Nervous System in Rosacea

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.

Study Overview

• Status: Recruiting
• Conditions: Rosacea
• Intervention / Treatment: Other: systemic and local stressors

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Metzler-Wilson, PT, PhD; Phone Number: 317-278-1871; Email: dptlab@iupui.edu
• Study Contact Backup: Name: Thad Wilson, PhD; Email: thad.wilson@uky.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Kristen Metzler-Wilson, PT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autonomic responses to stressors; Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Marian University
• Investigators: Principal Investigator: Kristen Metzler-Wilson, PT, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: autonomic nervous system; skin blood flow; skin sympathetic nerve activity
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 1R15AR069912-01A1 (U.S. NIH Grant/Contract)

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