Role of the Sympathetic Nervous System in Rosacea

NCT03989492 | Completed DMC

• 2 other identifiers: 957711R15AR069912-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rosacea

Keywords

autonomic nervous system; skin blood flow; skin sympathetic nerve activity

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Autonomic responses to stressors

EXPERIMENTAL

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

Interventions

systemic and local stressors OTHER

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.

Autonomic responses to stressors

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristen Metzler-Wilson: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristen Metzler-Wilson, PT, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 18, 2019
• Study Start: May 24, 2019
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)