Role of the Sympathetic Nervous System in Rosacea

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03989492
Collaborator
Marian University (Other)
210
1
1
26.3
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: systemic and local stressors
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Role of the Sympathetic Nervous System in Rosacea
Actual Study Start Date :
May 24, 2019
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skin blood flow [Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.]

    laser Doppler flowmetry

  2. Skin sympathetic nerve activity [Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.]

    microneurography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University
  • Marian University

Investigators

  • Principal Investigator: Kristen Metzler-Wilson, PT, PhD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristen Metzler-Wilson, Associate Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT03989492
Other Study ID Numbers:
  • 1R15AR069912-01A1
First Posted:
Jun 18, 2019
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
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
Keywords provided by Kristen Metzler-Wilson, Associate Professor, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021