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Role of the Sympathetic Nervous System in Rosacea

Primary Purpose

Rosacea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
systemic and local stressors
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rosacea focused on measuring autonomic nervous system, skin blood flow, skin sympathetic nerve activity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autonomic responses to stressors

Arm Description

Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.

Outcomes

Primary Outcome Measures

Skin blood flow
laser Doppler flowmetry
Skin sympathetic nerve activity
microneurography

Secondary Outcome Measures

Full Information

First Posted
June 12, 2019
Last Updated
September 25, 2023
Sponsor
Indiana University
Collaborators
Marian University
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1. Study Identification

Unique Protocol Identification Number
NCT03989492
Brief Title
Role of the Sympathetic Nervous System in Rosacea
Official Title
Role of the Sympathetic Nervous System in Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Marian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
autonomic nervous system, skin blood flow, skin sympathetic nerve activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autonomic responses to stressors
Arm Type
Experimental
Arm Description
Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.
Intervention Type
Other
Intervention Name(s)
systemic and local stressors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin blood flow
Description
laser Doppler flowmetry
Time Frame
Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.
Title
Skin sympathetic nerve activity
Description
microneurography
Time Frame
Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Metzler-Wilson, PT, PhD
Phone
317-278-1871
Email
dptlab@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thad Wilson, PhD
Email
thad.wilson@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Metzler-Wilson, PT, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Metzler-Wilson, PT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of the Sympathetic Nervous System in Rosacea

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